Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)

Not Applicable

Not yet recruiting

• Conditions: Obesity; Diabetes Mellitus Type 2 in Obese
• Interventions: Behavioral: Weight loss-induced Diabetes Remission

• Registration Number: NCT06333132
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.

Detailed Description

Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:

* measurement of fasting glucose and glycated hemoglobin

* Indirect calorimetry

* oral glucose tolerance test

* intravenous glucose tolerance test

* quality of life and diet-related questionnaires

* 72-hour food records

At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Study Start: 2024-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• T2D for less than 6 years;
• age 18-65 years;
• both genders;
• BMI 27-45 kg/m2;
• HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).

Exclusion Criteria

• type 1 or secondary/genetic diabetes;
• treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;
• weight loss >5% within the previous 6 months;
• eGFR <30 ml/min/1.73m2;
• myocardial infarction within the previous 6 months;
• severe heart failure (NYHA III-IV); eating disorder; substance abuse;
• severe depression;
• known cancer;
• pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obese subjects with type 2 diabetes mellitus	Weight loss-induced Diabetes Remission	Individualized weight-loss nutritional intervention

Primary Outcome Measures

Name	Time	Method
Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission	12 weeks	The investigators will test whether diabetes remission obtained after 10% weight-loss, induced by an intensive nutritional intervention, is associated with an improvement of the incretin effect from baseline.; Diabetes remission will be defined according to the latest international consensus as an HbA1c \<48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy.; The restoration of the incretin effect will be assessed by measuring both incretin levels and estimated incretin mediated insulin secretion before and after achieving the weight loss during an Oral Glucose Tolerance Test followed by an intravenous Glucose Tolerance Test.

Secondary Outcome Measures

Name	Time	Method
Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months	36 weeks	Diabetes remission will be defined according to the latest international consensus as an HbA1c \<48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy.; Thus, diabetes remission will be assessed after the end of the intervention phase (V1). Participants who will achieve diabetes remission at V1 will be monitored by measuring HbA1c for the next 6 months at 3-month intervals (V2 and V3).

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy