Caloric Restriction and Insulin Secretion
|ClinicalTrials.gov Identifier: NCT01447524|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : October 6, 2011
Caloric restriction in obese diabetic patients quickly improves glucose control, independently from weight loss. However, the early effects of a very-low calorie diet (VLCD) on insulin sensitivity and insulin secretion in morbidly obese patients with type 2 diabetes are still unclear.
The objective of this study was to investigate the relative contributions of insulin sensitivity and/or secretion to the improvement in glucose metabolism, after one week of caloric restriction, in severely obese diabetic patients.
For this purpose, hyperglycemic clamps were performed in 14 severely obese (BMI> 40 kg/m2) patients with type 2 diabetes in good glucose control (HbA1c <7.5%), before and after 7 days on VLCD 400 kcal/day.
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Type 2 Diabetes Mellitus||Behavioral: Very Low Calorie Diet||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Very Low Calorie Diet: a Quick Therapeutic Tool to Improve Beta Cell Function in Morbidly Obese Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
- Behavioral: Very Low Calorie Diet
Very Low Calorie Diet consisted of a 400 kcal/day diet, with percentage distribution of lipids, proteins and carbohydrates, according to Italian Standards of Care.
- Change from baseline in insulin sensitivity at 7 days [ Time Frame: At baseline and after 7 days of Very Low Calorie Diet ]Insulin sensitivity was measured at baseline (hospital entry) and after a 7 day very low calorie diet.
- Change from baseline in insulin secretion at 7 days. [ Time Frame: At baseline and after 7 days of Very Low Calorie Diet ]Insulin secretion was measured at baseline (hospital entry) and after a 7 day very low calorie diet.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447524
|San Giovanni Calibita Fatebenefratelli Hospital|
|Rome, Italy, 00186|
|Study Chair:||Simona Frontoni, MD, PhD||University of Rome Tor Vergata- Diabetes, Fatebenefratelli Hospital, Rome|