MicroalbuminuriaNCT02068833
Resolution of Microalbuminuria and Dysmetabolism Following Bariatric Surgery: Prospective Study
An observational study of Microalbuminuria and Gastrectomy, run by Laval University at 1 site in Canada.
Trial summary
Favorable effects of bariatric surgery have been demonstrated in particular regarding increased insulin sensitivity, decreased blood pressure, improved blood lipids and decreased cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Microalbuminuria, Gastrectomy, Biliopancreatic Diversion With Duodenal Switch
- What is being tested?
- Gastrectomy and BPD-DS
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2016
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will include patients 18 years and older with microalbuminuria (albumin/creatinine ratio between 2.0 and 20.0 mg/mmol in men and between 2.8 and 28.0 mg/mmol in women) planned to undergo either biliopancreatic diversion with sleeve gastrectomy or sleeve gastrectomy alone.
Who may be able to join
- Patient showing preoperative microalbuminuria (albumine/creatinine ratio between 2.0 and 20.0 in men and between 2.8 and 28.0 in women
- Men and Women between 18-60 years old;
- BMI ≥ 40 kg/m2 or between 35 and 40 kg/m2 if they have high-risk comorbidities;
- Subjects capable of understanding and being able to sign a consent form;
- Subjects capable of following the protocol directives, including the proposed visits (timeline);
- Subjects living within a reasonable distance from the hospital and capable of being present at all required visits.
Who cannot join
- Urinary infection;
- Hematuria (2+ or more) on 2 urinary analyses performed at 1 week interval;
- Hyperglycemia > 11 mmol/L at the time of the 2 urinary analyses;
- Known renal disease unrelated to hypertension or diabetes, normoalbuminuria, macroalbuminuria or proteinuria;
- Pregnant women or women who plan on becoming pregnant during the study, or women in fertile age range who refuse proper contraceptive methods during the study. (Must have negative pregnancy test at moment of enrolment and use medically acceptable contraception which include; oral contraceptives, injectable or implantable contraceptives, intrauterine devices or double-barrier method ie. condoms and diaphragm);
- Previous oesophagal, gastric or bariatric surgery;
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- Irritable bowel syndrome, unexplained intermittent vomiting, severe abdominal pain, diarrhea or chronic constipation;
- History of duodenal or gastric ulcers;
- History of renal disease, hepatic disease (cirrhosis) or severe cardiac or pulmonary disease;
- Corticosteroid intake in the previous month;
- Presence of psychiatric problems or behavioral issues that could limit subject's capacity at understanding the procedure and to conform to medical/surgical recommendations;
- History of drug use or alcoholism in previous 12 months before study;
- History of inflammatory diseases of the gastro-intestinal tract (Esophagitis, varices, gastric or duodenal ulcers, Crohn's disease, congenital or acquired anomalies of the digestive tract).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CRIUCPQ
Québec, Quebec, G1V4G5
Marc Lapointe, 4184558221, marc.lapointe@criucpq.ulaval.ca
André Tchernof
About this study
Favorable effects of bariatric surgery have been demonstrated in particular regarding increased insulin sensitivity, decreased blood pressure, improved blood lipids and decreased cardiovascular risk. After surgery, weight loss also leads to improvement of the chronic inflammatory state related to obesity, a strong predictor of the metabolic status. Although obese patients are often affected with type 2 diabetes and hypertension, both related to renal impairment, the existence of a distinct mechanism by which obesity would cause chronic renal insufficiency has been suggested. The mechanisms underlying obesity-related nephropathy have been proposed to involve hyperfiltration, expansion of mesangial cells, hyperperfusion leading to proteinuria and glomerulosclerosis, as noted in obese dogs. In humans, improvements in renal function may be observed following bariatric surgery, although some reported a possibility of increased nephrolithiases. Whether biliopancreatic diversion and gastrectomy alone have similar effects is uncertain. More prospective studies are needed to assess the impact of all types of weight loss surgery to reverse chronic renal insufficiency.
The objective of this study is to document changes in microalbuminuria and metabolic parameters in patients with altered renal function undergoing bariatric surgery. Patients enrolled in the study will show renal function impairment as demonstrated by albumin/creatinine ratio alterations in 2 out of 3 measurements taking place before surgery. We will perform a prospective study of renal function markers (albumin/creatinine ratio) and metabolic parameters (blood lipids, glucose, insulin, inflammatory markers) before and 6, 12, 24 months after surgery in patients with microalbuminuria at study onset (albumin/creatinine ratio 2.0-20.0 mg/mmol in men and 2.8-28.0 mg/mmol in women). Data will be analysed with repeated measures analyses in both subgroup. Thereafter, a linear regression model will be created to adjust for potentially confounding factors such as hypertension and diabetes. We hypothesize that patients with severe obesity and altered renal function, whether they are diabetic or not, have improved microalbuminuria and metabolic parameters following biliopancreatic diversion with sleeve gastrectomy or sleeve gastrectomy alone. The extent of renal function recovery will correlate directly with metabolic improvements.
- Being tested
- Gastrectomy, BPD-DS
- Keywords
- Microalbuminuria, Gastrectomy, Biliopancreatic Diversion With Duodenal Switch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrectomyProcedure or surgery
BPD-DSProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gastrectomy | Subjects in this group will undergo a gastrectomy only. Receives: Procedure: Gastrectomy | |
| BPD-DS | Subjects in this group will undergo a BPD-DS surgery. Receives: Procedure: BPD-DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in A/C Ratio
- A/C Ratio
- Weight Loss
Measured: Baseline, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroalbuminuriaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068833
- Sponsor's protocol ID
- 20839
- Status last verified
- May 2014
- First submitted
- 6 Feb 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Microalbuminuria and Dysmetabolism Following Bariatric Surgery: Prospective Study
- ClinicalTrials.gov ID
- NCT02068833
- Acronym / sponsor ID
- 20839
- Keywords
- Microalbuminuria, Gastrectomy, Biliopancreatic Diversion With Duodenal Switch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Feb 2014 (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.
Favorable effects of bariatric surgery have been demonstrated in particular regarding increased insulin sensitivity, decreased blood pressure, improved blood lipids and decreased cardiovascular risk. After surgery, weight loss also leads to improvement of the chronic inflammatory state related to obesity, a strong predictor of the metabolic status. Although obese patients are often affected with type 2 diabetes and hypertension, both related to renal impairment, the existence of a distinct mechanism by which obesity would cause chronic renal insufficiency has been suggested. The mechanisms underlying obesity-related nephropathy have been proposed to involve hyperfiltration, expansion of mesangial cells, hyperperfusion leading to proteinuria and glomerulosclerosis, as noted in obese dogs. In humans, improvements in renal function may be observed following bariatric surgery, although some reported a possibility of increased nephrolithiases. Whether biliopancreatic diversion and gastrectomy alone have similar effects is uncertain. More prospective studies are needed to assess the impact of all types of weight loss surgery to reverse chronic renal insufficiency.
The objective of this study is to document changes in microalbuminuria and metabolic parameters in patients with altered renal function undergoing bariatric surgery. Patients enrolled in the study will show renal function impairment as demonstrated by albumin/creatinine ratio alterations in 2 out of 3 measurements taking place before surgery. We will perform a prospective study of renal function markers (albumin/creatinine ratio) and metabolic parameters (blood lipids, glucose, insulin, inflammatory markers) before and 6, 12, 24 months after surgery in patients with microalbuminuria at study onset (albumin/creatinine ratio 2.0-20.0 mg/mmol in men and 2.8-28.0 mg/mmol in women). Data will be analysed with repeated measures analyses in both subgroup. Thereafter, a linear regression model will be created to adjust for potentially confounding factors such as hypertension and diabetes. We hypothesize that patients with severe obesity and altered renal function, whether they are diabetic or not, have improved microalbuminuria and metabolic parameters following biliopancreatic diversion with sleeve gastrectomy or sleeve gastrectomy alone. The extent of renal function recovery will correlate directly with metabolic improvements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrectomy | – | Procedure: GastrectomySubjects in this group will undergo a gastrectomy only. |
| BPD-DS | – | Procedure: BPD-DSSubjects in this group will undergo a BPD-DS surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include patients 18 years and older with microalbuminuria (albumin/creatinine ratio between 2.0 and 20.0 mg/mmol in men and between 2.8 and 28.0 mg/mmol in women) planned to undergo either biliopancreatic diversion with sleeve gastrectomy or sleeve gastrectomy alone.
Key inclusion criteria (6 listed)
- Patient showing preoperative microalbuminuria (albumine/creatinine ratio between 2.0 and 20.0 in men and between 2.8 and 28.0 in women
- Men and Women between 18-60 years old;
- BMI ≥ 40 kg/m2 or between 35 and 40 kg/m2 if they have high-risk comorbidities;
- Subjects capable of understanding and being able to sign a consent form;
- Subjects capable of following the protocol directives, including the proposed visits (timeline);
Key exclusion criteria (13 listed)
- Urinary infection;
- Hematuria (2+ or more) on 2 urinary analyses performed at 1 week interval;
- Hyperglycemia > 11 mmol/L at the time of the 2 urinary analyses;
- Known renal disease unrelated to hypertension or diabetes, normoalbuminuria, macroalbuminuria or proteinuria;
- Pregnant women or women who plan on becoming pregnant during the study, or women in fertile age range who refuse proper contraceptive methods during the study. (Must have negative pregnancy test at moment of enrolment and use medically acceptable contraception which include; oral contraceptives, injectable or implantable contraceptives, intrauterine devices or double-barrier method ie. condoms and diaphragm);
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 |
|---|---|---|
| Gastrectomy | Procedure or surgery | Gastrectomy |
| BPD-DS | Procedure or surgery | BPD-DS |
Primary outcome
Changes in A/C Ratio
Time frame: Baseline, 6, 12, 24 months
* A/C Ratio * Weight Loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microalbuminuria and Gastrectomy, run by Laval University at 1 site in Canada.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 May 2014. 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Lapointe (4186568711 ext. 2136, marc.lapointe@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in A/C Ratio (time frame: Baseline, 6, 12, 24 months). 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 16 May 2014.