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

NCT01213212 | Completed Phase 2

• 1 other identifier: CRESO
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Mellitus

Keywords

Caloric restriction; type 2 diabetes; abdominal obesity; renal disease

Outcome Measures

Primary Outcomes (1)

• Glomerular Filtration Rate (GFR), absolute and percent change, at 6 months vs baseline.

  0 and 6 month.

Secondary Outcomes (5)

• Renal Plasma Flow (RPF)

  At baseline, 3 and 6 month

• Filtration Fraction (FF)

  At baseline, 3 and 6 month

• Renal Vascular Resistance (RVR)

  At baseline, 3 and 6 month.

• Albuminuria

  At baseline, 3 and 6 month.

• Metabolic and inflammatory parameters.

  At baseline and 6 month

Study Arms (2)

Caloric restriction

EXPERIMENTAL

Caloric restriction

Other: Caloric restriction

Diet "ad libitum"

SHAM COMPARATOR

Diet "ad libitum"

Other: No intervention

Interventions

Caloric restriction OTHER

Caloric restriction.

Caloric restriction

No intervention OTHER

Diet "ad libitum"

Diet "ad libitum"

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Clinical Research Center for Rare Diseases

Ranica, Bergamo, 24020, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Abdominal; Kidney Diseases

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

IT (1)