Diabetes Mellitus Type 2 in Obese, Obesity
Conditions
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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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.
Interventions
BEHAVIORALWeight 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
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months | 36 weeks | 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). |
Countries
Italy
Contacts
Primary ContactDomenico Tricò, MD, PhD
Backup ContactLuca Sacchetta, MD
Outcome results
None listed