Resolution of Microalbuminuria and Dysmetabolism Following Bariatric Surgery: Prospective Study

NCT ID: NCT02068833

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

Brief 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. 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.

Conditions

Microalbuminuria; Gastrectomy; Biliopancreatic Diversion With Duodenal Switch

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Gastrectomy

Subjects in this group will undergo a gastrectomy only.

Gastrectomy

Intervention Type: PROCEDURE

BPD-DS

Subjects in this group will undergo a BPD-DS surgery.

BPD-DS

Intervention Type: PROCEDURE

Interventions

Gastrectomy

Intervention Type: PROCEDURE

BPD-DS

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRIUCPQ

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marc Lapointe

Role: CONTACT

marc.lapointe@criucpq.ulaval.ca

4186568711 ext. 2136

Mélanie Nadeau

Role: CONTACT

melanie.nadeau@criucpq.ulaval.ca

4186568711 ext. 3490

Facility Contacts

Marc Lapointe

Role: primary

marc.lapointe@criucpq.ulaval.ca

4184558221

Other Identifiers

20839

Identifier Type: -

Identifier Source: org_study_id