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Preventing Renal Functional Abnormalities With Calorie Restriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk (CRESO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213212
First Posted: October 1, 2010
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
  Purpose

The study investigates whether a caloric restricted dietary regime can prevent onset and/or progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity, through the amelioration of concomitant metabolic abnormalities such as insulin resistance, dyslipidemia, hypertension and inflammation, possible risk factors for the onset of kidney disease.

The main aim of the study is therefore to evaluate the renoprotective effect of caloric restriction (CR) on subjects at risk of nephropathy. Secondary aim is to better understand how dietary implementation can modulate renal disease and its associated metabolic abnormalities.


Condition Intervention Phase
Diabetes Mellitus Other: Caloric restriction Other: No intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Renal Functional Abnormalities Predisposing to Chronic Kidney Disease in Abdominal Obesity: A Randomized, Parallel-Group, Pilot Study of Calorie REstriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Glomerular Filtration Rate (GFR), absolute and percent change, at 6 months vs baseline. [ Time Frame: 0 and 6 month. ]

Secondary Outcome Measures:
  • Renal Plasma Flow (RPF) [ Time Frame: At baseline, 3 and 6 month ]
  • Filtration Fraction (FF) [ Time Frame: At baseline, 3 and 6 month ]
  • Renal Vascular Resistance (RVR) [ Time Frame: At baseline, 3 and 6 month. ]
  • Albuminuria [ Time Frame: At baseline, 3 and 6 month. ]
  • Metabolic and inflammatory parameters. [ Time Frame: At baseline and 6 month ]

Enrollment: 73
Study Start Date: September 2009
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caloric restriction
Caloric restriction
Other: Caloric restriction
Caloric restriction.
Sham Comparator: Diet "ad libitum"
Diet "ad libitum"
Other: No intervention
Diet "ad libitum"

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >40 years
  • Type 2 diabetes (ADA criteria)
  • Waist circumference > 94 cm (males) or > 80 cm (females)
  • UAE <20 μg/min
  • Serum creatinine < 1.2 mg/dL
  • No major changes in calorie, protein and sodium intake and in concomitant treatments with blood pressure, glucose or lipid lowering agents
  • Patients legally able to give written informed consent to the trial (signed and dated by the patient)
  • Written informed consent.

Exclusion Criteria:

  1. Concomitant non-diabetic renal disease:

    • ischemic kidney disease
    • primary or immune-mediated renal disease
    • urinary tract obstruction or infection.
  2. Concomitant treatments or clinical conditions that may affects renal hemodynamics and/or albuminuria:

    • ACE inhibitors and/or angiotensin II receptor blockers /ARBs
    • steroids and/or non-steroid antiinflammatory agents
    • 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)
    • heart failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hypo natremia of any cause)
  3. Other general conditions:

    • 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
    • any primary endocrinological diseases
    • unwillingness or inability to adhere to the rigors of the CR intervention over the entire 6-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 benefit of the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213212


Locations
Italy
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
ClinicalTrials.gov Identifier: NCT01213212     History of Changes
Other Study ID Numbers: CRESO
First Submitted: September 30, 2010
First Posted: October 1, 2010
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Mario Negri Institute for Pharmacological Research:
Caloric restriction
type 2 diabetes
abdominal obesity
renal disease

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