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

NCT ID: NCT06333132

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-02-01

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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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

Conditions

Obesity; Diabetes Mellitus Type 2 in Obese

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obese subjects with type 2 diabetes mellitus

Individualized weight-loss nutritional intervention

Group Type: EXPERIMENTAL

Weight loss-induced Diabetes Remission

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natali

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Domenico Tricò, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Countries

Italy

Central Contacts

Domenico Tricò, MD, PhD

Role: CONTACT

d.trico@unipi.it

050993640

Luca Sacchetta, MD

Role: CONTACT

luca.sacchetta@spec-med.unipi.it

050993640

Other Identifiers

DiabEAT.it

Identifier Type: -

Identifier Source: org_study_id