We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caloric Restriction and Insulin Secretion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447524
First Posted: October 6, 2011
Last Update Posted: October 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Simona Frontoni, University of Rome Tor Vergata
  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: 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

Resource links provided by NLM:


Further study details as provided by Simona Frontoni, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: September 30, 2011
First Posted: October 6, 2011
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