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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
Sponsor:
Information provided by (Responsible Party):
Simona Frontoni, University of Rome Tor Vergata

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 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)
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
Study Start Date : January 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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.


Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Publications:

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
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011

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