CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Standardized Lipid mealsdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02067585
NCT02067585N/ACompleted

An Analysis of Lipid and Glucose Metabolism Following Bariatric Surgery

University of Alberta·interventional·Posted Feb 20, 2014·Updated Apr 11, 2017

In Brief

A clinical study evaluating Standardized Lipid meals for Morbid Obesity. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Bariatric surgery induce remarkable weight loss and improvement or resolution of type 2 diabetes. Obesity is the primary risk factor for type 2 diabetes, and 90% of all type 2 diabetics are obese. Type 2 diabetes resolves post-operatively in 84-98% after bypass and 48-68% after restrictive procedures. Obesity leads to elevated plasma free fatty acids and subsequently to excessive accumulation of triglyceride in peripheral tissues, which is an independent risk factor for insulin resistance and type 2 diabetes. Bariatric surgery is associated with dramatic decrease in plasma free fatty acids and other lipids. This study will clarify the relationship of changes in fatty acid and other lipid metabolism to improved insulin sensitivity after different bariatric procedures ('restrictive' - laparoscopic adjustable gastric band and 'hybrid' - laparoscopic roux-en-y gastric bypass) and compare them with non-surgical obese patients. This will allow the investigators to refine indications for these procedures especially in patients with type 2 diabetes. The investigators will analyze whether surgical bypass of the upper small bowel plays a critical role in the resolution of type 2 diabetes and improvement in lipid metabolism. The investigators will achieve this by comparing gastric banding and gastric bypass in a collaborative research study involving obesity surgeons, physicians and lipid researchers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2014
Enrollment StartFeb 1, 2010
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.4 years ago

Interventions

Standardized Lipid mealsdietary

Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.