PROJECT ALEXANDRIA Knowledge Unit reader

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A six-month periodic fasting reduces microalbuminuria and improves metabolic control in patients with type 2 diabetes and diabetic nephropathy: a randomized controlled study

Gemma 4 12B IT · KU LoRA rank 128 · 1,000-word source chunks · guarded TranslateGemma 4B back-translation

Complete extractionLongest literal run: 18 words
Source title
A six-month periodic fasting reduces microalbuminuria and improves metabolic control in patients with type 2 diabetes and diabetic nephropathy: a randomized controlled study
Source authors
Alba Sulaj; Stefan Kopf; Ekaterina Von Rauchhaupt; Elisabeth Kliemank; Maik Brune; Zoltan Kender; Hannelore Bartl; Fabiola Garcia Cortizo; Katarina Klepac; Zhe Han; Varun Kumar; Valter Longo; Aurelio Teleman; Jürgen G Okun; Jakob Morgenstern; Thomas Fleming; Julia Szendroedi; Stephan Herzig; Peter P Nawroth
KU document title
A six-month periodic fasting reduces microalbuminuria and improves metabolic control in patients with type 2 diabetes and diabetic nephropathy: a randomized controlled study
KU document author field
Not populated by the original extractor
Style annotation
No dedicated document-style field in this schema
KU sequence
5 of 5 expected chunks
Attribution provenance
Source registry metadata shown for attribution; not added to the QA context

This condition scores 84.0% (168/200) across all 20 evaluation papers. The example page does not imply that every claim in this individual paper is correct.

Gemma 4 12B IT · KU LoRA rank 128 · 500 wordsGemma 4 12B IT · KU LoRA rank 128 · 1,000 wordsGemma 4 E4B IT · KU LoRA rank 128 · 500 wordsGemma 4 E4B IT · KU LoRA rank 128 · 1,000 wordsQwen 3.8 27B FP8 · teacher · 500 wordsQwen 3.8 27B FP8 · teacher · 1,000 words

Every saved KU, entity, attribute and relationship is shown below, in original chunk order. Navigation follows the source sequence rather than publication dates. Adjacent summaries are reader navigation, not lookahead supplied to extraction. All KUs were generated before the paraphrasing stage. Download complete factual KU JSON.

Jump to KU: 12345

KU 1 · source words 1–995

10 entities · 14 relationships · 0 preceding KUs available during extraction

Recorded context summary

A randomized controlled study evaluated the effects of a fasting-mimicking diet on patients with type 2 diabetes and diabetic nephropathy. The intervention aimed to reduce albuminuria and assess changes in metabolic markers like HOMA-IR and senescence indicators. Results showed significant improvements in microalbuminuria and HOMA-IR, though these effects were not sustained at the three-month follow-up.

fasting-mimicking diet (FMD)

method · ID: fasting_mimicking_diet_fmd
duration
six months
cycle_structure
five-day diet intervention followed by refeeding
adherence_monitoring
dietary protocols and ketone body measurements

Relationships

  • reduced → microalbuminuria
    magnitude
    -30.3 mg/g
    significance
    P ≤ 0.05
  • reduced → HOMA-IR
    magnitude
    -3.8
    significance
    P ≤ 0.05
  • reduced → suPAR
    magnitude
    -156.6 pg/ml
    significance
    P ≤ 0.05
  • did_not_change → markers of dicarbonyl detoxification
  • did_not_change → DNA-damage/repair markers

Mediterranean diet

method · ID: mediterranean_diet
role
control group
duration
six months

Relationships

  • compared_to → fasting-mimicking diet (FMD)

type 2 diabetes and diabetic nephropathy patients

other · ID: type_2_diabetes_and_diabetic_nephropathy_patients
sample_size
40
baseline_HbA1c
7.8±0.2% [62.1±2.3 mmol/mol]
inclusion_criteria
Increased albumin-to-creatinine ratio (ACR), good blood sugar control, and blood pressure control
randomization
21 to FMD, 19 to Mediterranean diet
model_entity_type
population

Relationships

  • underwent → randomized controlled study

albuminuria reduction

other · ID: albuminuria_reduction
primary_endpoint
difference of change in ACR from baseline to six months
microalbuminuria_change
-30.3 mg/g
macroalbuminuria_change
434.0 mg/g
overall_change_difference
110.3 mg/g
model_entity_type
outcome

Relationships

  • sustained_at_follow_up → false
    reason
    lack of changes in markers of dicarbonyl detoxification and DNA-damage/repair

HOMA-IR reduction

other · ID: homa_ir_reduction
magnitude
-3.8
significance
P ≤ 0.05
model_entity_type
outcome

Relationships

  • sustained_at_follow_up → true
    magnitude
    -1.9
    significance
    P ≤ 0.05

suPAR

measurement · ID: supar
description
marker of senescence
change_magnitude
-156.6 pg/ml
significance
P ≤ 0.05

Relationships

  • affected_by → fasting-mimicking diet (FMD)

dicarbonyl detoxification markers

measurement · ID: dicarbonyl_detoxification_markers
components
MG-H1, glyoxalase-1, hydroxyacetone
change
no change observed

Relationships

  • associated_with → relapse of albuminuria at follow-up

DNA-damage/repair markers

measurement · ID: dna_damage_repair_markers
components
(yH2Ax)
change
no change observed

Relationships

  • associated_with → relapse of albuminuria at follow-up

acylcarnitines

measurement · ID: acylcarnitines
description
markers of lipid oxidation
finding
change in profile related to patient responsiveness to ACR improvement

Relationships

  • correlated_with → ACR improvement

University Hospital of Heidelberg

organization · ID: university_hospital_of_heidelberg
location
Germany
ethics_approval
Ethic-Nr. S-682/2016
registration
DRKS-ID: DRKS00014287

Relationships

  • conducted → randomized controlled study
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Previous KU: Start of paper
Next KU: The study utilized a stratified randomization procedure to assign patients to either a fasting-mimicking diet or a Mediterranean diet intervention. Participants followed the prescribed diets for five days each month, with specific caloric and macronutrient targets for the fasting-mimicking diet. The primary endpoint was the absolute difference in change of ACR from baseline to after six diet cycles between the two groups.

KU 2 · source words 996–1,975

8 entities · 10 relationships · 1 preceding KUs available during extraction

Recorded context summary

The study utilized a stratified randomization procedure to assign patients to either a fasting-mimicking diet or a Mediterranean diet intervention. Participants followed the prescribed diets for five days each month, with specific caloric and macronutrient targets for the fasting-mimicking diet. The primary endpoint was the absolute difference in change of ACR from baseline to after six diet cycles between the two groups.

stratified computed randomization procedure

method · ID: stratified_computed_randomization_procedure
software_version
2.0.3
institution
Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz
stratification_factors
BMI (cut-off 30.0 kg/m²) and HbA1c (cut-off 7.0%)

Relationships

  • assigned_participants_to → intervention or control group

fasting-mimicking diet (FMD)

method · ID: fasting_mimicking_diet_fmd
type
plant-based
day_1_energy
4600 kJ
day_1_macronutrients
11% protein, 46% fat, 43% carbohydrates
days_2_to_5_energy
3000 kJ
days_2_to_5_macronutrients
9% protein, 44% fat, 47% carbohydrate

Relationships

  • mimics_effects_on → glucose and ketone bodies
  • requires_discontinuation_of → short-acting insulin
  • requires_reduction_of → long-acting insulin by 50%
  • requires_discontinuation_of → oral antidiabetic therapy

Mediterranean Diet (M-Diet)

method · ID: mediterranean_diet_m_diet
caloric_change
no change compared to baseline
adaptation_standard
Mediterranean Diet Score (MDS)

Relationships

  • assigned_to → control group

primary endpoint

measurement · ID: primary_endpoint
definition
absolute difference of change of ACR from baseline to after six diet cycles between FMD and M-Diet group

Relationships

  • includes_subgroup_analysis_for → micro-versus macroalbuminuria levels at baseline

secondary endpoints

measurement · ID: secondary_endpoints
time_points
after three diet cycles and after six diet cycles
markers
HOMA-IR, plasma MG-H1, plasma MG, Glo-1 activity, expression of pGlo-1 in WBC, hydroxyacetone in RBC, plasma AC profile, yH2Ax expression in WBC, suPAR

Relationships

  • uses_hierarchical_test_procedure_to_account_for → multiple testing

sample size calculation

method · ID: sample_size_calculation
software
PASS 16.0.12
required_n
34
estimated_dropout_rate
15%
final_n
40
significance_level
alpha=5%
power
at least 80%
standard_deviation_assumption
30% for both groups

Relationships

  • based_on_clinically_relevant_reduction_of → albuminuria by at least 30%

statistical analysis

method · ID: statistical_analysis
population
intention-to-treat
missing_value_handling
not imputed
analysis_type
available-case analysis
comparison_method
ANCOVA was adjusted to account for age, gender, weight loss, and the initial value.
software
R (version 3.6.1 2019-07-05)
visualization_tools
R core packages, tiduverse, pheatmap, GraphPad Prism version 5.00

Relationships

No relationships recorded.

patient characteristics

event · ID: patient_characteristics
study_period
March 2018 to May 2020
total_randomized
41
fmd_group_n
21
m_diet_group_n
20
discontinued_immediately
1
reason_for_discontinuation
erysipelas
completed_three_cycles
38
completed_study
33
seen_at_follow_up
31
follow_up_time
112±31 days
main_reason_for_withdrawal
Covid-19 pandemic restrictions

Relationships

  • baseline_measures_comparable_between → study groups
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Previous KU: A randomized controlled study evaluated the effects of a fasting-mimicking diet on patients with type 2 diabetes and diabetic nephropathy. The intervention aimed to reduce albuminuria and assess changes in metabolic markers like HOMA-IR and senescence indicators. Results showed significant improvements in microalbuminuria and HOMA-IR, though these effects were not sustained at the three-month follow-up.
Next KU: The study compared a fasting-mimicking diet (FMD) to a Mediterranean diet (M-Diet) in patients with type 2 diabetes and diabetic nephropathy, finding significant reductions in microalbuminuria, HOMA-IR, and suPAR levels. Weight loss was greater in the FMD group, but body composition remained unchanged between groups when adjusted for weight. Most metabolic improvements, including ACR reduction and MG-H1 changes, reversed at follow-up, while HOMA-IR reduction was sustained.

KU 3 · source words 1,976–2,958

11 entities · 24 relationships · 2 preceding KUs available during extraction

Recorded context summary

The study compared a fasting-mimicking diet (FMD) to a Mediterranean diet (M-Diet) in patients with type 2 diabetes and diabetic nephropathy, finding significant reductions in microalbuminuria, HOMA-IR, and suPAR levels. Weight loss was greater in the FMD group, but body composition remained unchanged between groups when adjusted for weight. Most metabolic improvements, including ACR reduction and MG-H1 changes, reversed at follow-up, while HOMA-IR reduction was sustained.

fasting-mimicking diet (FMD)

method · ID: fasting_mimicking_diet_fmd
tolerance
well tolerated
adverse_effects
71-95% reported no adverse effects
common_symptoms
weakness, muscle pain, dizziness, headache
severe_adverse_effects
none reported

Relationships

  • reduced_acr_in_microalbuminuria_patients → 54% reduction after six cycles
    p_value
    <=0.05
  • reduced_acr_in_macroalbuminuria_patients → 434.0 mg/g difference after six cycles
    p_value
    0.23
  • reduced_urea_levels → 11.8 mg/dl after three cycles; 17.9 mg/dl after six cycles
    p_value
    <=0.01 for three cycles; <=0.05 for six cycles
  • preserved_egfr_more_than_m_diet → 8.3 ml/min/1.73m² difference after six cycles
    p_value
    <=0.05
  • reduced_supar_levels → 214.8 pg/ml after three cycles; 156.6 pg/ml after six cycles
    p_value
    <=0.05 for both
  • reduced_hba1c_levels → 17% reduction after six cycles
    p_value
    <=0.05
  • reduced_homa_ir_in_non_insulin_treated → 60% reduction after six cycles
    p_value
    <=0.05
  • caused_weight_loss → 5.6 kg after three cycles; 7.2 kg after six cycles
    p_value
    <=0.001
  • reduced_mg_h1_levels → 62% reduction after three cycles

Mediterranean diet (M-Diet)

method · ID: mediterranean_diet_m_diet

No attributes recorded.

Relationships

  • caused_weight_loss → 0.7 kg after three cycles; 1.1 kg after six cycles
    p_value
    <=0.001

ACR (Albumin-to-Creatinine Ratio)

measurement · ID: acr_albumin_to_creatinine_ratio
baseline_fmd_responders
85.7 mg/g
baseline_fmd_non_responders
271 mg/g
baseline_m_diet_responders
55.5 mg/g
baseline_m_diet_non_responders
563.0 mg/g

Relationships

  • difference_in_change_after_six_cycles_all_patients → 110.3 mg/g
    p_value
    0.45
  • difference_in_change_after_three_cycles_all_patients → -62.5 mg/g
    p_value
    0.45
  • reversed_at_follow_up → baseline values

HOMA-IR

measurement · ID: homa_ir

No attributes recorded.

Relationships

  • sustained_reduction_at_follow_up → -1.9
    p_value
    <=0.05

HbA1c

measurement · ID: hba1c

No attributes recorded.

Relationships

  • no_change_after_three_cycles → FMD group
  • reversed_at_follow_up → baseline values

FPG (Fasting Plasma Glucose)

measurement · ID: fpg_fasting_plasma_glucose

No attributes recorded.

Relationships

  • no_change_after_six_cycles → between study groups

LDL, HDL, Triglycerides

measurement · ID: ldl_hdl_triglycerides

No attributes recorded.

Relationships

  • no_change_throughout_study → FMD group compared to M-Diet and baseline

Body Composition

measurement · ID: body_composition
fat_mass
no change
fat_free_mass
no change

Relationships

  • no_change_between_groups → when adjusted for weight loss

MG-H1

measurement · ID: mg_h1

No attributes recorded.

Relationships

  • no_association_with_acr_change → in both M-Diet and FMD groups
  • reversed_at_follow_up → baseline values

AC Profile (Acetylcarnitine)

measurement · ID: ac_profile_acetylcarnitine
C2_level_change
increased after three cycles in responders

Relationships

  • distinct_response_in_responders → compared to non-responders
  • reversed_at_follow_up → baseline values

Study Participants

person · ID: study_participants
gender_distribution
74% male in M-Diet, 71% male in FMD
medication_change
most increased antihyperglycemic medication except three FMD participants

Relationships

  • no_difference_in_endpoints_by_gender → female and male participants
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Previous KU: The study utilized a stratified randomization procedure to assign patients to either a fasting-mimicking diet or a Mediterranean diet intervention. Participants followed the prescribed diets for five days each month, with specific caloric and macronutrient targets for the fasting-mimicking diet. The primary endpoint was the absolute difference in change of ACR from baseline to after six diet cycles between the two groups.
Next KU: The study found that fasting-mimicking diet (FMD) cycles significantly reduced antihyperglycemic and antihypertensive medications compared to the Mediterranean diet (M-Diet). Blood ketones increased three-fold in the FMD group, while high MDS scores in the M-Diet group indicated good compliance. The intervention improved microalbuminuria and HOMA-IR, but these effects were largely transient and reversed after refeeding.

KU 4 · source words 2,959–3,938

13 entities · 14 relationships · 3 preceding KUs available during extraction

Recorded context summary

The study found that fasting-mimicking diet (FMD) cycles significantly reduced antihyperglycemic and antihypertensive medications compared to the Mediterranean diet (M-Diet). Blood ketones increased three-fold in the FMD group, while high MDS scores in the M-Diet group indicated good compliance. The intervention improved microalbuminuria and HOMA-IR, but these effects were largely transient and reversed after refeeding.

fasting-mimicking diet (FMD)

method · ID: fasting_mimicking_diet_fmd
safety
safe and well tolerated
effect_on_medication
reduced antihyperglycemic and antihypertensive medications
effect_on_ketones
increased 3-fold after three and six cycles
effect_on_albuminuria
reduced ACR in patients with microalbuminuria, no effect in macroalbuminuria
effect_on_homa_ir
sustained improvement
effect_on_mg_h1
transient reduction
effect_on_supar
transient reduction
effect_on_dna_damage_repair
no change
effect_on_dicarbonyl_detoxification
no change
effect_on_glycine
increased in responders
effect_on_acetylcarnitine
increased in responders
effect_on_glo_1
no change in activity or expression

Relationships

  • compared_to → Mediterranean diet (M-Diet)
  • induced_by → prolonged fasting periods

Mediterranean diet (M-Diet)

method · ID: mediterranean_diet_m_diet
compliance_indicator
high MDS score (6.1)
effect_on_medication
increased antihyperglycemic and antihypertensive medications in some participants
effect_on_ketones
not reported as increased
effect_on_albuminuria
no reduction in ACR

Relationships

  • compared_to → fasting-mimicking diet (FMD)

hypoglycemic episodes

measurement · ID: hypoglycemic_episodes
grade_1_fmd
10%
grade_1_m_diet
11%
grade_2_fmd
5%
grade_2_m_diet
11%
difference_between_groups
did not differ

Relationships

  • occurred_during → diet intervention

antihyperglycemic medication

measurement · ID: antihyperglycemic_medication
fmd_reduction_3_cycles
57%
m_diet_reduction_3_cycles
32%
m_diet_increase_3_cycles
5%
fmd_reduction_6_cycles
67%
m_diet_increase_6_cycles
21%

Relationships

  • reduced_by → fasting-mimicking diet (FMD)

antihypertensive medication

measurement · ID: antihypertensive_medication
fmd_reduction_3_cycles
10%
m_diet_reduction_3_cycles
5%
m_diet_increase_3_cycles
5%
fmd_reduction_6_cycles
10%
m_diet_increase_6_cycles
10%

Relationships

  • reduced_by → fasting-mimicking diet (FMD)

blood ketones

measurement · ID: blood_ketones
fmd_increase_3_cycles
3-fold (0.50 mmol)
fmd_increase_6_cycles
3-fold (0.50 mmol)
p_value
P≤0.001

Relationships

  • increased_in → fasting-mimicking diet (FMD) group

MDS score

measurement · ID: mds_score
m_diet_3_cycles
6.1
m_diet_6_cycles
6.1
interpretation
sign of good compliance

Relationships

  • reported_in → Mediterranean diet (M-Diet) group

microalbuminuria

concept · ID: microalbuminuria
pathogenesis
pathogenic events targeting vasculature, glomerulus, and tubular cells
fmd_effect
reduced ACR levels
fmd_effect_macroalbuminuria
no change in ACR levels
comparison
comparable to reduction in SGLT-2 inhibitors
refeeding_effect
rapid increase at refeeding points

Relationships

  • reduced_by → fasting-mimicking diet (FMD)

HOMA-IR

measurement · ID: homa_ir
fmd_effect
sustained improvement
adjustment
even if weight loss is taken into account

Relationships

  • improved_by → fasting-mimicking diet (FMD)

acetylcarnitine

measurement · ID: acetylcarnitine
fmd_effect
increased in responders
cause
Strong activation of lipolysis during a prolonged fasting period
uncertainty
unclear if marker of compliance or substrate for renal metabolism

Relationships

  • discriminates → responders and non-responders with respect to ACR improvement

glycine

measurement · ID: glycine
fmd_effect
increased in responders
protective_effect
protective effects on renal tubular injury
mechanism
might enhance Glo-1 function and restore antioxidant defense

Relationships

  • discriminates → responders and non-responders with respect to ACR improvement

suPAR

measurement · ID: supar
fmd_effect
transient reduction
definition
Indicator of accelerated aging and senescence
post_fmd_increase
fast increase after FMD

Relationships

  • reduced_by → fasting-mimicking diet (FMD)

SGLT-2 inhibitors

method · ID: sglt_2_inhibitors
effect_on_albuminuria
reduction in microalbuminuria
mechanism
induction of mild ketogenesis shifting energy metabolism to ketolysis

Relationships

  • compared_to → fasting-mimicking diet (FMD)
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Previous KU: The study compared a fasting-mimicking diet (FMD) to a Mediterranean diet (M-Diet) in patients with type 2 diabetes and diabetic nephropathy, finding significant reductions in microalbuminuria, HOMA-IR, and suPAR levels. Weight loss was greater in the FMD group, but body composition remained unchanged between groups when adjusted for weight. Most metabolic improvements, including ACR reduction and MG-H1 changes, reversed at follow-up, while HOMA-IR reduction was sustained.
Next KU: The study concludes that fasting-mimicking diet cycles can be integrated into clinical practice to reduce albuminuria and insulin resistance in type 2 diabetes patients with microalbuminuria. It notes that the lack of activation in specific nephropathy defense pathways and absence of changes in dicarbonyl detoxification markers may explain the relapse of albuminuria after six cycles. The study shows that a significant weight loss was achieved, but the reduction in albuminuria was likely independent of the weight loss, as it continued even after re-feeding.

KU 5 · source words 3,939–4,701

8 entities · 9 relationships · 4 preceding KUs available during extraction

Recorded context summary

The study concludes that fasting-mimicking diet cycles can be integrated into clinical practice to reduce albuminuria and insulin resistance in type 2 diabetes patients with microalbuminuria. It notes that the lack of activation in specific nephropathy defense pathways and absence of changes in dicarbonyl detoxification markers may explain the relapse of albuminuria after six cycles. The study shows that a significant weight loss was achieved, but the reduction in albuminuria was likely independent of the weight loss, as it continued even after re-feeding.

fasting-mimicking diet (FMD)

method · ID: fasting_mimicking_diet_fmd
clinical_integration
complementary to current guidelines
effect_on_insulin_resistance
sustained reduction even when adjusted for weight loss
effect_on_albuminuria
reduction in patients with microalbuminuria
effect_on_metabolism
sustained redirection of metabolism

Relationships

  • requires_longer_period_for → nephropathy reversal
  • shows_different_response_in → MG-H1 reduction after three vs six cycles

nephropathy defense pathways

concept · ID: nephropathy_defense_pathways
activation_status
not activated or newly combined in this study

Relationships

  • control → nephropathy

MG-H1 reduction

measurement · ID: mg_h1_reduction
response_pattern
Different depending on three, but not on six, FMD cycles.

Relationships

  • suggests_not_due_to → reduced energy intake during FMD

study limitations

concept · ID: study_limitations
control_group_diet
isocaloric
fmd_group_diet
caloric restriction
sample_size
small
renal_cell_metabolism_exploration
limited due to lack of kidney biopsies

Relationships

  • adjusted_for → weight loss

albuminuria reduction

measurement · ID: albuminuria_reduction
significance
significant in subgroup analysis of patients with microalbuminuria
independence_from_weight_loss
likely independent as weight loss persists at refeeding while albuminuria increases

Relationships

  • predictor_of → development of diabetic nephropathy

dicarbonyl detoxification markers

measurement · ID: dicarbonyl_detoxification_markers
change_status
no significant change

Relationships

  • may_explain → relapse of albuminuria after six FMD cycles

DNA-damage/repair markers

measurement · ID: dna_damage_repair_markers
change_status
no significant change

Relationships

  • may_explain → relapse of albuminuria after six FMD cycles

incomplete lipid oxidation markers

measurement · ID: incomplete_lipid_oxidation_markers
effect_on_albuminuria
distinct effects in patients showing improvement

Relationships

  • may_help_develop → new therapeutic strategies
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Previous KU: The study found that fasting-mimicking diet (FMD) cycles significantly reduced antihyperglycemic and antihypertensive medications compared to the Mediterranean diet (M-Diet). Blood ketones increased three-fold in the FMD group, while high MDS scores in the M-Diet group indicated good compliance. The intervention improved microalbuminuria and HOMA-IR, but these effects were largely transient and reversed after refeeding.
Next KU: End of paper