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

Obesity Clinical Trial

— DiabEATit  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06333132
• Other study ID #: DiabEAT.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: March 2024
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Domenico Tricò, MD, PhD
• Phone: 050993640
• Email: d.trico[@]unipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: February 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus, Type 2
• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months	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).	36 weeks