Effects of Caloric Restriction in Obesity and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Behavioral: Calorie restriction (25%); Behavioral: Ad libitum health diet

• Registration Number: NCT01930136
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-28
• Status Verified: 2022-05
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calorie restriction (25%)	Calorie restriction (25%)	CR will correspond to a reduction of 25% from the total daily calorie expenditure calculated as Total Daily Energy Expenditure (TDEE) (kcal/d) using the formula from the validated Seven-Day Physical Activity Recall (PAR) Questionnaire (RMR x activity levels).
Ad libitum health diet	Ad libitum health diet	-

Primary Outcome Measures

Name	Time	Method
The percent change in glomerular filtration rate (GFR) at month 6 versus baseline and the rate of GFR decline from month 6 to study end	At baseline, 6, 12 and 24 month

Trial Locations

Locations (1)

Clinical Research Center for Rare Diseases; 🇮🇹 Ranica, Bergamo, Italy