Weight Loss Improves Renal Hemodynamics
Primary Purpose
Obesity, Metabolic Syndrome, Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
dietary intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity focused on measuring Obesity, Metabolic Syndrome, Microalbuminuria, Chronic Kidney Disease
Eligibility 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
Sites / Locations
- NIEPEN
Outcomes
Primary Outcome Measures
Renal Hemodynamics
Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.
Secondary Outcome Measures
Full Information
NCT ID
NCT01356394
First Posted
May 11, 2011
Last Updated
May 18, 2011
Sponsor
Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
Collaborators
Federal University of Juiz de Fora
1. Study Identification
Unique Protocol Identification Number
NCT01356394
Brief Title
Weight Loss Improves Renal Hemodynamics
Official Title
Weight Loss Improves Renal Hemodynamics in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
Collaborators
Federal University of Juiz de Fora
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome, Chronic Kidney Disease
Keywords
Obesity, Metabolic Syndrome, Microalbuminuria, Chronic Kidney Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
dietary intervention
Other Intervention Name(s)
calorie-restricted diet
Intervention Description
12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat
Primary Outcome Measure Information:
Title
Renal Hemodynamics
Description
Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogerio B de Paula, PhD
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIEPEN
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36036-330
Country
Brazil
12. IPD Sharing Statement
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