Meal Stimulating After Roux-en Y Gastric Bypass

NCT00915980 | Completed DMC

• 1 other identifier: H-C-2007-0108
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests that the remission of the T2DM is due to the direct effect of the operation, more than the secondary effect of the weight loss. The reasons for the major effect on the glucose metabolism after gastric bypass surgery are still unaccounted for. The aim of this project will be to unveil some of the mechanisms that explain the effect of gastric bypass surgery on the glucose metabolism. Further more to find a better way of testing patients that have just undergone gastric bypass surgery. It is not possible to test patients who have just undergone gastric bypass surgery with normal oral glucose tolerance test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose level and meal-testing with a protein drink. The hypothesis of the study is that the investigators can see changes in different hormones and adipokines before and after surgery, even with modified OGTT and meal testing. The project will consist of clinical trials on patients without T2DM that will undergo gastric bypass surgery. The studies will take place before and within the first week after surgery. The investigators will measure different hormones and adipokines after OGTT and a meal with a protein drink. The investigators expect to see significant changes in some of the analyses after the operation in patients undergoing gastric bypass.

Conditions

Gastric Bypass; Obesity

Keywords

Meal-test; reduced OGTT; gastric bypass surgery and glucose metabolism; Glucose metabolism before and after gastric bypass; Different OGTT; New meal- test

Study Arms (1)

Patients without diabetes undergoing gastric bypass

Procedure: gastric bypass surgery and testing

Interventions

gastric bypass surgery and testing PROCEDURE

The patients will be tested with OGTT and meal testing before and after undergoing gastric bypass surgery.

Patients without diabetes undergoing gastric bypass

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese with BMI \> 40 undergoing gastric bypass surgery or obese with BMI \> 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery.

You may qualify if:

• Obese with BMI\> 40 undergoing gastric bypass surgery OR
• Obese with BMI \> 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery
• Age between 20-60 years

You may not qualify if:

• Age \> 60
• Diabetes
• Psychiatric illness
• Mentally challenged
• Addiction
• Serious cardiac or lung diseases
• Diseases in the abdomen
• Other serious illness

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Hvidovre hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum sampels for analysis of primarily intestinal hormones

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2010
• Last Updated: July 8, 2011

Record last verified: 2011-07

Locations

DK (1)