CHRONIC FASTING AND THE DIABETIC LATE COMPLICATIONS: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY IN PATIENTS WITH DIABETES MELLITUS TYPE 2

CHRONIC FASTING AND THE DIABETIC LATE COMPLICATIONS: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY IN PATIENTS WITH DIABETES MELLITUS TYPE 2 - FMD-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014287

Enrollment

Registered

2018-03-14

Start date

2018-03-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic nephropathy E11

Interventions

Group 1: "fasting-mimicking-diet" for 5 days monthly, for a total of 3-6 months The diabetic late complications (diabetic nephropathy, retinopathy, neuropathy and lung function test) will be evaluate

Eligibility

Sex/Gender

All

Age

50 Years to 75 Years

Inclusion criteria

Inclusion criteria: - men and women capable of consent, age 50-75 years, - subjects with diabetes mellitus Typ 2 and already documented increased albuminuria (albuminuria >=20mg/l or >=20 mg/g urine-creatinine for men and >=30 mg/g Urine-creatinine for women) in two consecutive spontaneous urinalysis, - eGFR>30 ml/min/173cm² (CKD-EPI Formula), - diabetes duration min. 1 year, - diabetes therapy with oral antidiabetic drugs, Insulin and/or diet, - BMI 23-40kg/m².

Exclusion criteria

Exclusion criteria: - incapability of consent, - secondary form of diabetes (ADA-criteria type 3 B-H), - acute infection/fever, - immunosuppressive therapy, - severe diseases of heart, kidney or liver: -- NYHA stage IV -- not-diabetic liver diseases -- severe peripheral arterial disease -- not-diabetic nephropathy - alcohol abuse or other drugs, - tumor diseases in the last 5 years, - Hepatitis B, C, E, HIV infection, - autoimmune diseases under immunsuppressive therapy, - participation in other intervention studies, - anemia or hematological diseases, - other causes of neuropathy or polyneuropathy (autoimmune, alcohol- induced, vitamin-B12-defficiency neuropathy, collagenosis), - exclusion criteria for the pulmonary function tests, - food allergies

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the diabetic nephropathy. This will be evaluted by the change of albuminuria. Albuminuria will be measured at baseline, after 3 months and after 6 months using a quantitative method for the albumin concentration in urine.	—

Secondary

Measure	Time frame
Composite endpoint score of diabetic late complications Cellular resistance against dicarbonyl stress after 1 month diet intervention with fasting-mimicking diet and after glucose load with oral 75 g glucose intake	—

Countries

Germany

Contacts

Public ContactAlba Sulaj

Universitätsklinikum Heidelberg

Alba.Sulaj@med.uni-heidelberg.de+4962215639826

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026