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

Primary Purpose

Type 2 Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Calorie restriction (25%)
Ad libitum health diet
Sponsored by
Mario Negri Institute for Pharmacological Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Calorie restriction, Type 2 diabetes, Obesity, Diabetic nephropathy prevention

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Center for Rare Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calorie restriction (25%)

Ad libitum health diet

Arm Description

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).

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2013
Last Updated
May 5, 2022
Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
Istituto Superiore di Sanità
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1. Study Identification

Unique Protocol Identification Number
NCT01930136
Brief Title
Effects of Caloric Restriction in Obesity and Type 2 Diabetes
Acronym
CRESO2
Official Title
Long-term Effects of Caloric Restriction on Metabolic, Renal End Retinal Health in Subjectsaffected by Obesityand Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
Istituto Superiore di Sanità

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
Keywords
Calorie restriction, Type 2 diabetes, Obesity, Diabetic nephropathy prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calorie restriction (25%)
Arm Type
Experimental
Arm Description
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).
Arm Title
Ad libitum health diet
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Calorie restriction (25%)
Intervention Type
Behavioral
Intervention Name(s)
Ad libitum health diet
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinical Research Center for Rare Diseases
City
Ranica
State/Province
Bergamo
ZIP/Postal Code
24020
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
35219762
Citation
Ruggenenti P, Cortinovis M, Trillini M, Parvanova A, Abbate M, Satriano C, Salvetti F, Bossi AC, Trevisan R, Perna A, Peracchi T, Rubis N, Diadei O, Martinetti D, Gaspari F, Fontana L, Remuzzi G; CRESO 2 Study; Organization. Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial). Diabetes Res Clin Pract. 2022 Mar;185:109804. doi: 10.1016/j.diabres.2022.109804. Epub 2022 Feb 24.
Results Reference
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Effects of Caloric Restriction in Obesity and Type 2 Diabetes

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