Status:
COMPLETED
Caloric Restriction and Insulin Secretion
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Morbid Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief 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...
Detailed Description
In obese patients with type 2 diabetes mellitus, lifestyle modifications resulting in weight loss improve or even normalize blood glucose. This beneficial effect on glucose control is accounted for by...
Eligibility Criteria
Inclusion
- diet or oral hypoglycaemic agents
- morbid obesity (BMI \> 40kg/m2)
- good metabolic control (HbA1C \<7.5%)
Exclusion
- treatment with GLP-1 agonists, DPP-4 inhibitors, insulin
- serum creatinine \>150 µmol/l
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01447524
Start Date
January 1 2010
End Date
March 1 2011
Last Update
October 6 2011
Active Locations (1)
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1
San Giovanni Calibita Fatebenefratelli Hospital
Rome, Italy, 00186