Diabetes Mellitus, Type 2, Nutrition, Healthy, Obesity, Weight Loss
Conditions
Brief summary
In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes
Interventions
BEHAVIORALeTRC diet
12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch
BEHAVIORALControl diet
12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age 18-75 years * both males and females * type 2 diabetes
Exclusion criteria
* type 1 diabetes * insulin treatment * pharmacological treatment for weight loss * pregnancy * other acute or chronic conditions influencing body weight and glucose metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 12 weeks | Change in plasma levels of glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose tolerance | 12 weeks | Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute mixed meal tolerance test (MMTT) |
| Body weight loss | 12 weeks | Change in body weight |
Other
| Measure | Time frame | Description |
|---|---|---|
| Daily glucose variability | 14 days | Glucose variability will be measured as the coefficient of variation (CV) of glucose levels recorded by continuous glucose monitoring over a 14-day period using a FreeStyle Libre 2 sensor |
| Beta cell function | 12 weeks | Beta cell function will be measured as the beta cell glucose sensitivity obtained from mathematical modeling of plasma glucose and C-peptide levels in response to a 180-minute mixed meal tolerance test (MMTT) |
Countries
Italy
Outcome results
None listed