Status:
COMPLETED
Preventing Renal Functional Abnormalities With Calorie Restriction in Subjects With Abdominal Obesity and Type 2 Diabetes at Increased Renal and Cardiovascular Risk
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Istituto Superiore di Sanità
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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 amelio...
Detailed Description
Background: Obesity is the major risk factor for type 2 diabetes, which in turn is associated with nephropathy in about one third of patients. Obesity is also an independent risk factor for chronic r...
Eligibility Criteria
Inclusion
- 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
- Concomitant non-diabetic renal disease:
- ischemic kidney disease
- primary or immune-mediated renal disease
- urinary tract obstruction or infection.
- 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)
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01213212
Start Date
September 1 2009
End Date
February 1 2013
Last Update
February 21 2013
Active Locations (1)
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1
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020