NCT01930136

Effects of Caloric Restriction in Obesity and Type 2 Diabetes

Long-term Effects of Caloric Restriction on Metabolic, Renal End Retinal Health in Subjectsaffected by Obesityand Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

• Type 2 Diabetes
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Calorie restriction (25%)
BEHAVIORAL	Ad libitum health diet

Timeline

• Start date: 2013-05-01
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2013-08-28
• Last updated: 2022-05-06

Locations

1 site across 1 country: Italy