CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
weight loss by very low energy diet intake which may differ in protein or carbohydrate contentbehavioral
Likely dose
Not stated in record
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Search/NCT05295160
NCT05295160N/ACompleted

Fasting-Associated Immune-metabolic Remission of Diabetes Type 2

Charite University, Berlin, Germany·interventional·Posted Mar 24, 2022·Updated Aug 30, 2023

In Brief

A clinical study evaluating weight loss by very low energy diet intake which may differ in protein or carbohydrate content for Type 2 Diabetes Mellitus and Obesity. Completed, enrolled 52 participants across 1 site.

Detailed Summary

People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (HbA1c \<6.5% without medication) of diabetes in over 80% upon weight loss of 15 kg. Longer duration of diabetes reduced the chance of remission. The investigators will test whether there is a difference in remission upon weight loss of 15 kg using formula low calorie diets between subjects with a diabetes duration of \<4 years vs. \>8 years and oral treatment as primary end points. The immune metabolic programming of circulating monocytes will be investigated in detail regarding trained innate immunity and the endocrine responses will be determined using meal challenge tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 24, 2022
Enrollment StartSep 25, 2020
Primary CompletionDec 31, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.3 years ago

Interventions

weight loss by very low energy diet intake which may differ in protein or carbohydrate contentbehavioral

The anthropometric, endocrine and metabolic status is tested before, after 7 days and after 15 kg weight loss