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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy
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.
Time frame: 12 weeks
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).
Time frame: 36 weeks
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