Caloric Restriction and Insulin Secretion
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|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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|