Weight Loss Improves Renal Hemodynamics

Weight Loss Improves Renal Hemodynamics in Patients With Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Chronic Kidney Disease
• Intervention / Treatment: Other: dietary intervention

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
• Collaborators: Federal University of Juiz de Fora
• Investigators: Principal Investigator: Rogerio B de Paula, PhD, professor

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 19, 2011
• Last Update Submitted That Met QC Criteria: May 18, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Obesity; Metabolic Syndrome; Chronic Kidney Disease; Microalbuminuria
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Disease; Renal Insufficiency; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Syndrome; Kidney Diseases; Renal Insufficiency, Chronic; Metabolic Syndrome; Weight Loss
• Other Study ID Numbers: 273/2006