NCT06333132

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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.

Conditions

• Obesity
• Diabetes Mellitus Type 2 in Obese

Interventions

Type	Name	Description
BEHAVIORAL	Weight loss-induced Diabetes Remission	Patients will undergo a dietary intervention plus drugs (if needed) with the purpose to obtain a 10% (or at least 10 kg) body weight reduction to achieve diabetes remission

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2026-02-01
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: Italy