Weight Loss Improves Renal Hemodynamics

NCT01356394 | Completed Phase 4

• 1 other identifier: 273/2006
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic syndrome (MS) is a clustering of risk factors for cardiovascular disease (CVD) such as hypertension, hypertriglyceridemia, low HDL-cholesterol levels, disorders of glucose metabolism, and insulin resistance. A number of associated conditions are included in the MS spectrum such as abdominal obesity, systemic inflammatory activation, endothelial dysfunction, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, and microalbuminuria. As a consequence, the diagnosis of MS identifies patients who are at increased risk for type 2 diabetes mellitus and CVD. In the last few years, the potential for MS to trigger renal damage and accelerate the progression of pre-existing nephropathy has become a focus of research. Some studies have suggested that MS can influence the development of CKD, although the underlying mechanisms are not well understood. In this study, the investigators hypothesized that modifying a key component of the MS, namely obesity, could attenuate renal damage. The investigators examined the impact of weight loss on creatinine clearance and urinary albumin excretion in non-diabetic obese patients with MS.

Conditions

Obesity; Metabolic Syndrome; Chronic Kidney Disease

Keywords

Obesity; Metabolic Syndrome; Microalbuminuria; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Renal Hemodynamics

  Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.

  12 weeks

Interventions

dietary intervention OTHER

12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat

Also known as: calorie-restricted diet

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female
• Age: 20 to 65 years old
• Metabolic syndrome according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III

You may not qualify if:

• fasting plasma glucose \> 126 mg/dL or a history of diabetes mellitus
• hypertension stage 2 or 3
• glomerulonephritis
• CKD stages 3, 4, or 5
• severe heart or lung disease
• pregnancy

Sponsors & Collaborators

• Nucleus of Education Interdisciplinary Research and Treatment in Nephrology: lead
• Federal University of Juiz de Fora: collaborator

Study Sites (1)

NIEPEN

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Renal Insufficiency, Chronic

Interventions

Diet Therapy; Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rogerio B de Paula, PhD

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 19, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2010-01

Locations

BR (1)