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The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.
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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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:
At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese subjects with type 2 diabetes mellitus | Experimental | Individualized weight-loss nutritional intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico Tricò, MD, PhD | Contact | 050993640 | d.trico@unipi.it | |
| Luca Sacchetta, MD | Contact | 050993640 | luca.sacchetta@spec-med.unipi.it |
| Name | Affiliation | Role |
|---|---|---|
| Domenico Tricò, MD, PhD | University of Pisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Pisana | Pisa | PI | 56127 | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 36 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |