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

NCT06333132 | Not Yet Recruiting

• 1 other identifier: DiabEAT.it
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Diabetes Mellitus Type 2 in Obese

Outcome Measures

Primary Outcomes (1)

• Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission

  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.

  12 weeks

Secondary Outcomes (1)

• Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months

  36 weeks

Study Arms (1)

Obese subjects with type 2 diabetes mellitus

EXPERIMENTAL

Individualized weight-loss nutritional intervention

Behavioral: Weight loss-induced Diabetes Remission

Interventions

Weight loss-induced Diabetes Remission 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

Obese subjects with type 2 diabetes mellitus

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Domenico Tricò, MD, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Tricò, MD, PhD

CONTACT

050993640; d.trico@unipi.it

Luca Sacchetta, MD

CONTACT

050993640; luca.sacchetta@spec-med.unipi.it

Study Design

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

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 27, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)