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Effects of Caloric Restriction in Obesity and Type 2 Diabetes

NCT01930136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-05-06

No results posted yet for this study

Summary

The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation.

The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.

Conditions

Interventions

BEHAVIORAL

Calorie restriction (25%)

BEHAVIORAL

Ad libitum health diet

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    collaborator OTHER

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2022-05-05
Completion
2022-05-05

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 NCT01930136 on ClinicalTrials.gov