Fasting-Associated Immune-metabolic Remission of Diabetes

NCT05295160 | Completed

• 1 other identifier: FAIR-EFSD
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Obesity

Keywords

type 2 diabetes mellitus in obese; insulin secretion; innate immunity; monocyte programming; remission of type 2 diabetes; weight loss

Outcome Measures

Primary Outcomes (1)

• Concentration of fasting blood glucose < 126 mg/deciliter

  Remission of type 2 diabetes defined by a concentration of a fasting blood glucose \< 126 mg/deciliter without diabetes medication

  3 month

Secondary Outcomes (2)

• Immune-metabolic profile and programing of innate immunity

  before, after 7 days and after 3 month

• Composition of the microbiome

  before, after 7 days and after 3 month

Study Arms (2)

type 2 diabetes - less than 4 years duration

OTHER

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

type 2 diabetes - more than 8 years

OTHER

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

Interventions

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

type 2 diabetes - less than 4 years duration; type 2 diabetes - more than 8 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Related Publications (2)

• Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

  PMID: 29221645 BACKGROUND

• Steven S, Hollingsworth KG, Al-Mrabeh A, Avery L, Aribisala B, Caslake M, Taylor R. Very Low-Calorie Diet and 6 Months of Weight Stability in Type 2 Diabetes: Pathophysiological Changes in Responders and Nonresponders. Diabetes Care. 2016 May;39(5):808-15. doi: 10.2337/dc15-1942. Epub 2016 Mar 21.

  PMID: 27002059 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Weight Loss

Interventions

Proteins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Andreas FH Pfeiffer, MD

  Universitätsmedizin Berlin CBF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Professor

Model Details: Obese people with type 2 diabetes with a duration of less then 4 years will be compared with people with type 2 diabetes for more than 8 years regarding their capability to achieve remission of type 2 diabetes in response to a weight loss of 15kg achived using very low calorie intake

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: March 24, 2022
• Study Start: September 25, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)