ObesityPhase 4NCT01356394
Weight Loss Improves Renal Hemodynamics
A Phase 4 study testing dietary intervention in people with Obesity and Metabolic Syndrome, run by Nucleus of Education Interdisciplinary Research and Treatment in Nephrology at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Metabolic Syndrome, Chronic Kidney Disease
- What is being tested?
- dietary intervention
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Feb 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Metabolic Syndrome, Chronic Kidney Disease
- Being tested
- dietary intervention
- Keywords
- Obesity, Metabolic Syndrome, Microalbuminuria, Chronic Kidney Disease
- Medical subject headings
- Obesity, Metabolic Syndrome, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionOther
Also called calorie-restricted diet
12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Hemodynamics
Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Juiz de Fora
- Investigators
- Rogerio B de Paula, PhD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356394
- Sponsor's protocol ID
- 273/2006
- Status last verified
- Jan 2010
- First submitted
- 11 May 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Improves Renal Hemodynamics in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01356394
- Acronym / sponsor ID
- 273/2006
- Conditions
- Obesity, Metabolic Syndrome, Chronic Kidney Disease
- Keywords
- Obesity, Metabolic Syndrome, Microalbuminuria, Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nucleus of Education Interdisciplinary Research and Treatment in NephrologyUniversity, hospital or other
- Collaborators
- Federal University of Juiz de Fora
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary interventionAlso: calorie-restricted diet12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogerio B de Paula, PhD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dietary intervention in people with Obesity and Metabolic Syndrome, run by Nucleus of Education Interdisciplinary Research and Treatment in Nephrology at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Hemodynamics (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.