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NCT Number: NCT05295160

Fasting-Associated Immune-metabolic Remission of Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Composition of the microbiome

    Time frame: before, after 7 days and after 3 month

    Percent changes in firmicutes in stool,

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Fasting-Associated Immune-metabolic Remission of Diabetes Type 2

Acronym: FAIR

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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