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Resolution of Microalbuminuria and Dysmetabolism Following Bariatric Surgery: Prospective Study

NCT02068833 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2014-05-16

No results posted yet for this study

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

Interventions

PROCEDURE

Gastrectomy

PROCEDURE

BPD-DS

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

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

    collaborator OTHER

  • Laval University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068833 on ClinicalTrials.gov