N/A
N=48
An Analysis of Lipid and Glucose Metabolism Following Bariatric Surgery
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02067585 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Triglycerides Post-prandial — 95; 71; 134 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standardized Lipid meals (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Triglycerides Post-prandial |
95; 71; 134 | — |
| PRIMARY Triglycerides |
93; 85; 115 | — |
| PRIMARY Triglyceride |
103; 59; 123 | — |
| PRIMARY Triglyceride |
103; 59; 123 | — |
| PRIMARY Triglyceride |
103; 59; 123 | — |
| SECONDARY Blood Glucose |
4.8; 4.7; 5.5 | — |
| SECONDARY Glucose |
4.8; 4.7; 4.9 | — |
| SECONDARY Glucose |
4.8; 4.7; 4.9 | — |
| SECONDARY Glucose |
4.8; 4.7; 4.9 | — |
| SECONDARY Glucose |
4.8; 4.7; 4.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- morbidly obese patients
- age 18-65
- with or without type 2 diabetes
- 12 or more months following LRYGB or LAGB, or patients waiting for mentioned procedures
- able to provide written informed consent.
Exclusion Criteria
- chronic liver disease
- maladaptive eating behavior
- current pharmacological treatment for obesity
- for patients following LAGB - ongoing band volume adjustments
- hypothyroidism
- treatment with insulin
- revision of a previous bariatric procedure
- major postoperative complication
- allergy to soy or any component of the study meal
- renal failure (glomerular filtration <60mL/min)
- alcoholism
- acute illness
- pregnancy or nursing.
Data sourced from ClinicalTrials.gov (NCT02067585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.