Caloric Restriction and Insulin Secretion

NCT01447524 | Completed DMC

• 1 other identifier: 48/2009
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Change from baseline in insulin sensitivity at 7 days

  Insulin sensitivity was measured at baseline (hospital entry) and after a 7 day very low calorie diet.

  At baseline and after 7 days of Very Low Calorie Diet

• Change from baseline in insulin secretion at 7 days.

  Insulin secretion was measured at baseline (hospital entry) and after a 7 day very low calorie diet.

  At baseline and after 7 days of Very Low Calorie Diet

Interventions

Very Low Calorie Diet BEHAVIORAL

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.

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• treatment with GLP-1 agonists, DPP-4 inhibitors, insulin
• serum creatinine \>150 µmol/l

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

San Giovanni Calibita Fatebenefratelli Hospital

Rome, 00186, Italy

Location

Related Publications (26)

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MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Simona Frontoni, MD, PhD

  University of Rome Tor Vergata- Diabetes, Fatebenefratelli Hospital, Rome

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 6, 2011
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

IT (1)