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:
Collaborator:
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01213212
First received: September 30, 2010
Last updated: February 20, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal Plasma Flow (RPF) [ Time Frame: At baseline, 3 and 6 month ] [ Designated as safety issue: No ]
  • Filtration Fraction (FF) [ Time Frame: At baseline, 3 and 6 month ] [ Designated as safety issue: No ]
  • Renal Vascular Resistance (RVR) [ Time Frame: At baseline, 3 and 6 month. ] [ Designated as safety issue: No ]
  • Albuminuria [ Time Frame: At baseline, 3 and 6 month. ] [ Designated as safety issue: No ]
  • Metabolic and inflammatory parameters. [ Time Frame: At baseline and 6 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01213212     History of Changes
Other Study ID Numbers: CRESO
Study First Received: September 30, 2010
Last Updated: February 20, 2013
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 14, 2014