Fasting-Associated Immune-metabolic Remission of Diabetes (FAIR)

August 29, 2023 updated by: Prof. Dr. med. Andreas F. H. Pfeiffer, Charite University, Berlin, Germany

Fasting-Associated Immune-metabolic Remission of Diabetes Type 2

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A remission of type 2 diabetes can be achieved in over 80% of people with a diagnosis within the last 4 years and overweight or obesity by weight loss of 15 kg. The mechanisms involve an improvement of insulin sensitivity and thereby insulin requirements and a regain of the function of insulin secreting beta cells. Longer duration of type 2 diabetes appears to impair the capacity of beta cell to regenerate. At present it is not possibe to predict success of the weight loss at an early time point. The investigators therefore aim to identify early markers of responders. It is unclear how the weight loss induces the remission in responders. Immune cells are known to contribute to insulin resistance by regulating adipose tissue function and hepatic and skeletal muscle metabolism by releasing cytokines. The inborn immune system is known to adapt to external stimuli by the process of trained immunity and is thought to contribute to insulin resistance and the dysfunction of beta-cells. The investigation will analyze the programming state of innate immune cells in detail in the course of diabetes remission. In addition, islet hormone responses to challenge tests will be performed to assess their function in detail.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes diagnosed less than 4 or over 8 years, before study,
  • BMI > 28 kg/m²,
  • willingness to follow weight loss diet,

Exclusion Criteria:

  • consuming disease,
  • intolerance for very low calorie formula diet,
  • known severe hepatic disease or liver cirrhosis,
  • type 1 diabetes,
  • severe disease of kidney or heart,
  • advanced diabetic retinopathy,
  • intake of glucocorticoids,
  • drug or alcohol abuse,
  • weight loss of >5 kg in the last 3 month,
  • eating disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: type 2 diabetes - less than 4 years duration
Patients with a duration of less than 4 years since diagnosis of type 2 diabetes, BMI > 28 kg/m², non-insulin treated who agree to loose 15 kg body weight by eating a very low calorie formula diet of 800 kcal/day for men and 600 kcal/day for women. The duration of the diet is until the weight loss is achieved.
Behavioral: weight loss by very low energy diet intake which may differ in protein or carbohydrate content
The anthropometric, endocrine and metabolic status is tested before, after 7 days and after 15 kg weight loss
Other: type 2 diabetes - more than 8 years
Patients with a duration of more than 8 years since diagnosis of type 2 diabetes, BMI > 28 kg/m², non-insulin treated who agree to loose 15 kg body weight by eating a very low calorie formula diet of 800 kcal/day for men and 600 kcal/day for women. The duration of the diet is until the weight loss is achieved.
Behavioral: weight loss by very low energy diet intake which may differ in protein or carbohydrate content
The anthropometric, endocrine and metabolic status is tested before, after 7 days and after 15 kg weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of fasting blood glucose < 126 mg/deciliter
Time Frame: 3 month
Remission of type 2 diabetes defined by a concentration of a fasting blood glucose < 126 mg/deciliter without diabetes medication
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune-metabolic profile and programing of innate immunity
Time Frame: before, after 7 days and after 3 month

Changes of cluster of differentiation 4/cluster of differentiation antigen 45 circulating immune cells in percent of CD4+ cells measured by flow cytometry in blood.

Concentrations of TNFalpha in pg/ml, changes of Momocyte Chemoattractant Protein-1 in pg/ml.
before, after 7 days and after 3 month
Composition of the microbiome
Time Frame: before, after 7 days and after 3 month
Percent changes in firmicutes in stool,
before, after 7 days and after 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Andreas FH Pfeiffer, MD, Universitätsmedizin Berlin CBF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAIR-EFSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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