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Caloric Restriction and Insulin Secretion

NCT01447524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-10-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Simona Frontoni, MD, PhD · University of Rome Tor Vergata- Diabetes, Fatebenefratelli Hospital, Rome

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447524 on ClinicalTrials.gov