Weight Loss Improves Renal Hemodynamics

• ClinicalTrials.gov Identifier: NCT01356394
• Recruitment Status: Completed
• First Posted: May 19, 2011
• Last Update Posted: May 19, 2011
• Sponsor: Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
• Collaborator: Federal University of Juiz de Fora
• Information provided by: Nucleus of Education Interdisciplinary Research and Treatment in Nephrology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Metabolic Syndrome; Chronic Kidney Disease	Other: dietary intervention	Phase 4

Detailed Description:

Non-diabetic patients with MS were recruited from an outpatient clinic at the Division of Nephrology of the Federal University of Juiz de Fora, Brazil. MS was defined according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII). The study was divided into two phases: phase 1 (baseline) and phase 2 (intervention). At the first study visit, a full medical history was taken and a clinical examination was performed. Blood samples were taken to determine plasma glucose levels, both after fasting and 2 h after a 75-g oral glucose overload (oral glucose tolerance test; OGTT), as well as levels of plasma insulin, creatinine, total cholesterol, HDL-cholesterol, triglycerides, and uric acid. At visit 2, the preliminary results were evaluated and urine samples were collected in duplicate for measurement of microalbuminuria. Creatinine clearance was estimated using the Cockcroft-Gault formula, corrected for body surface area. The subjects were kept free of any medication (statins, antihypertensive, and anti-inflammatory drugs) over the entire study period. The only medications allowed during the study were analgesics such as dipyrone and hioscin. At visit 3, each patient was evaluated by a registered dietitian with expertise in medical nutrition therapy with the aim of achieving a weight loss of at least 5% from baseline. Patients were commenced on a 12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat. The patients were evaluated by the dietitian every 2 weeks. At the final visit all laboratory tests were repeated. At the end of phase 2, patients were divided into two groups: responders, who had achieved at least a 5% reduction in body weight and non-responders, who had not achieved the target weight reduction.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Weight Loss Improves Renal Hemodynamics in Patients With Metabolic Syndrome
• Study Start Date: January 2010
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: February 2011

Arms and Interventions

Intervention Details:

• Other: dietary intervention
  12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat
  Other Name: calorie-restricted diet

Outcome Measures

Primary Outcome Measures :

1. Renal Hemodynamics [ Time Frame: 12 weeks ]
   Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Brazil

NIEPEN

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

Sponsors and Collaborators

Nucleus of Education Interdisciplinary Research and Treatment in Nephrology

Federal University of Juiz de Fora

Investigators

• Principal Investigator: Rogerio B de Paula, PhD; professor

More Information

• Responsible Party: Ezequiel, DGA, professor
• ClinicalTrials.gov Identifier: NCT01356394
• Other Study ID Numbers: 273/2006
• First Posted: May 19, 2011
• Last Update Posted: May 19, 2011
• Last Verified: January 2010

Keywords provided by Nucleus of Education Interdisciplinary Research and Treatment in Nephrology:

Obesity; Metabolic Syndrome; Microalbuminuria; Chronic Kidney Disease

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Metabolic Syndrome; Syndrome; Weight Loss; Disease; Pathologic Processes; Body Weight; Urologic Diseases; Renal Insufficiency; Body Weight Changes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases