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Caloric Restriction and Insulin Secretion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simona Frontoni, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT01447524
First received: September 30, 2011
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Morbid Obesity
Type 2 Diabetes Mellitus
 Behavioral: Very Low Calorie Diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Very Low Calorie Diet: a Quick Therapeutic Tool to Improve Beta Cell Function in Morbidly Obese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • Change from baseline in insulin sensitivity at 7 days [ Time Frame: At baseline and after 7 days of Very Low Calorie Diet ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Insulin secretion was measured at baseline (hospital entry) and after a 7 day very low calorie diet.


Enrollment: 14
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diet or oral hypoglycaemic agents
  • morbid obesity (BMI > 40kg/m2)
  • good metabolic control (HbA1C <7.5%)

Exclusion Criteria:

  • treatment with GLP-1 agonists, DPP-4 inhibitors, insulin
  • serum creatinine >150 µmol/l
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447524

Locations
Italy
San Giovanni Calibita Fatebenefratelli Hospital
Rome, Italy, 00186
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
Study Chair: Simona Frontoni, MD, PhD University of Rome Tor Vergata- Diabetes, Fatebenefratelli Hospital, Rome
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Simona Frontoni, MD, PhD, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01447524     History of Changes
Other Study ID Numbers: 48/2009
Study First Received: September 30, 2011
Last Updated: October 5, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013