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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mario Negri Institute for Pharmacological Research
Sponsor:
Collaborator:
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01930136
First received: August 23, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: LONG-TERM EFFECTS OF CALORIC RESTRICTION ON METABOLIC, RENAL AND RETINAL HEALTH IN SUBJECTS AFFECTED BY OBESITY AND TYPE 2 DIABETES

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: February 2016 (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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930136

Contacts
Contact: Piero Ruggenenti, MD 0039 035 45351 piero.ruggenenti@marionegri.it

Locations
Italy
Clinical Research Center for Rare Diseases Recruiting
Ranica, Bergamo, Italy, 24020
Principal Investigator: Giuseppe Remuzzi, MD         
Sub-Investigator: Stefano Rota, MD         
Sub-Investigator: Manuela Abbate, Biol Sci D         
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Istituto Superiore di Sanità
  More Information

No publications provided

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01930136     History of Changes
Other Study ID Numbers: CRESO 2
Study First Received: August 23, 2013
Last Updated: September 24, 2014
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014