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
  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:


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.
  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014