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

This study is ongoing, but not recruiting participants.
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research Identifier:
First received: August 23, 2013
Last updated: July 6, 2017
Last verified: July 2017

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.

Condition Intervention
Type 2 Diabetes Obesity Behavioral: Calorie restriction (25%) Behavioral: Ad libitum health diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01930136

Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Istituto Superiore di Sanità
  More Information

Responsible Party: Mario Negri Institute for Pharmacological Research Identifier: NCT01930136     History of Changes
Other Study ID Numbers: CRESO 2
Study First Received: August 23, 2013
Last Updated: July 6, 2017

Keywords provided by Mario Negri Institute for Pharmacological Research:
Calorie restriction
Type 2 diabetes
Diabetic nephropathy prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on September 21, 2017