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

Azienda Ospedaliero, Universitaria Pisana

Status

Not yet enrolling

Conditions

Diabetes Mellitus Type 2 in Obese

Obesity

Treatments

Behavioral: Weight loss-induced Diabetes Remission

Study type

Interventional

Funder types

Other

Identifiers

NCT06333132

DiabEAT.it

Details and patient eligibility

About

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

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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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

Enrollment

45 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.