NCT02067585

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 11, 2017

Completed
Last Updated

April 11, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

February 13, 2014

Results QC Date

January 9, 2017

Last Update Submit

February 28, 2017

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (5)

  • Triglycerides Post-prandial

    0 minutes

  • Triglycerides

    30 minutes

  • Triglyceride

    90 minutes

  • Triglyceride

    4 hours

  • Triglyceride

    6 hours

Secondary Outcomes (5)

  • Blood Glucose

    0 minute

  • Glucose

    30 minutes

  • Glucose

    90 minutes

  • Glucose

    4 hours

  • Glucose

    6 hours

Study Arms (3)

LAGB

EXPERIMENTAL

Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.

Dietary Supplement: Standardized Lipid meals

LRYGB

EXPERIMENTAL

Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.

Dietary Supplement: Standardized Lipid meals

Non-surgical

EXPERIMENTAL

Standardized Lipid meals will be served to the non-surgical obese patients

Dietary Supplement: Standardized Lipid meals

Interventions

Standardized Lipid mealsDIETARY_SUPPLEMENT

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.

LAGBLRYGBNon-surgical

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • morbidly obese patients
  • age 18-65
  • with or without type 2 diabetes
  • or more months following LRYGB or LAGB, or patients waiting for mentioned procedures
  • able to provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMIS

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Xinzhe Shi
Organization
Royal Alexandra Hospital
xinzhe.shi@ahs.ca
7807356735

Study Officials

  • Daniel W Birch, MD

    CAMIS, University of Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 20, 2014

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2012

Last Updated

April 11, 2017

Results First Posted

April 11, 2017

Record last verified: 2017-02

Locations

CA(1)