CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Very Low Calorie Dietbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01447524
NCT01447524N/ACompleted
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Very Low Calorie Diet: a Quick Therapeutic Tool to Improve Beta Cell Function in Morbidly Obese Patients With Type 2 Diabetes Mellitus

University of Rome Tor Vergata·interventional·Posted Oct 6, 2011·Updated Oct 6, 2011

In Brief

A clinical study evaluating Very Low Calorie Diet for Morbid Obesity and Type 2 Diabetes Mellitus. Completed, enrolled 14 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity, Type 2 Diabetes Mellitus
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2011
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.7 years ago

Interventions

Very Low Calorie Dietbehavioral

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.