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Weight Loss Improves Renal Hemodynamics

This study has been completed.
Sponsor:
Collaborator:
Federal University of Juiz de Fora
Information provided by:
Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
ClinicalTrials.gov Identifier:
NCT01356394
First received: May 11, 2011
Last updated: May 18, 2011
Last verified: January 2010
  Purpose

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 Intervention Phase
Obesity
Metabolic Syndrome
Chronic Kidney Disease
Other: dietary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Weight Loss Improves Renal Hemodynamics in Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Nucleus of Education Interdisciplinary Research and Treatment in Nephrology:

Primary Outcome Measures:
  • Renal Hemodynamics [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.


Enrollment: 58
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356394

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

No publications provided

Responsible Party: Ezequiel, DGA, professor
ClinicalTrials.gov Identifier: NCT01356394     History of Changes
Other Study ID Numbers: 273/2006
Study First Received: May 11, 2011
Last Updated: May 18, 2011
Health Authority: Brazil: Ministry of Health

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
Metabolic Syndrome X
Obesity
Renal Insufficiency, Chronic
Syndrome
Weight Loss
Body Weight
Body Weight Changes
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Renal Insufficiency
Signs and Symptoms
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014