Effects of Caloric Restriction in Obesity and Type 2 Diabetes (CRESO2)

May 5, 2022 updated by: Mario Negri Institute for Pharmacological Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bergamo
      • Ranica, Bergamo, Italy, 24020
        • Clinical Research Center for Rare Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age >40 years;
  • Type 2 diabetes (ADA criteria);
  • UAE <300 mg/24h;
  • Body mass index (BMI)>27kg/m2;
  • Serum creatinine < 1.2 mg/dL;
  • No major changes in calorie, protein and sodium intake in the last 6 mos;
  • No major changes in concomitant treatments with blood pressure, glucose or lipid lowering agents since 6 and 3 months respectively;
  • Patients legally able to give written informed consent to the trial (signed and dated by the patient);
  • Written informed consent.

Exclusion Criteria

  • Concomitant non-diabetic renal disease or ischemic kidney disease;
  • Primary or immune-mediated renal disease;
  • Urinary tract obstruction or infection;
  • Treatment with steroids and/or non-steroid anti-inflammatory agents;
  • Treatment with thiazide or loop diuretics that, on the basis of the Investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration);
  • Hearth failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hyponatremia of any cause;
  • Previous surgical procedures for weight loss;
  • Previous episodes of depression, or suicide attempts;
  • Chronic abuse of alcohol and drugs;
  • Pregnancy, ineffective contraception or peri-menopausal age;
  • Cancer or any chronic disease that might affect the completion of the study;
  • Chronic obstructive pulmonary disease (COPD) in treatment with positive airway pressure;
  • Unwillingness or inability to adhere to CR intervention over the entire 24-months intervention period;
  • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
  • Evidence of an uncooperative attitude;
  • Any evidence that patient will not be able to complete the trial follow-up;
  • Inability to fully understand the potential risks and benefits of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: Calorie restriction (25%)
Active Comparator: Ad libitum health diet
Behavioral: Ad libitum health diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: At baseline, 6, 12 and 24 month
At baseline, 6, 12 and 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Collaborators

Istituto Superiore di Sanità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

May 5, 2022

Study Completion (Actual)

May 5, 2022

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRESO 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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