Relationship Between Changes in Gut Hormones After Gastric Bypass and Gastric Banding and Improvements in Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01153438
First received: June 28, 2010
Last updated: April 26, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to see how hormones that control blood sugar change in response to two different weight loss surgeries (gastric bypass and gastric banding). We believe that changes in a hormone called glucagon-like peptide-1 (GLP-1) may account for the greater improvement in blood sugar after certain types of surgeries. GLP-1 makes the pancreas release insulin, a hormone that lowers blood sugar. The study will consist of one screening visit and three study visits in which the glucose response will be measured after drinking a liquid meal: 1) Visit 1 (2-3 weeks before surgery); 2) Visit 2 (after 10% of body weight is lost); and 3) Visit 3 (5-10 days after Visit 2). Hormone levels will be measured during the three study visits. To see if the improvement in blood sugar after surgery is due to changes in GLP-1, we will block its effect on insulin release by giving either salt water or a medication that blocks the activity of GLP-1 during the two visits that take place after surgery (Visits 2 and 3).


Condition Phase
Type 2 Diabetes
Obesity
Bariatric Surgery
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Role of Endogenous Glucagon-like Peptide-1 (GLP-1) in Improved Glucose Tolerance After Two Different Types of Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • change in glucose tolerance after surgery (measured by glucose area under the curve) [ Time Frame: after surgery when 10% of initial body weight is lost (expected 4 weeks after bypass and 12 weeks after banding) ] [ Designated as safety issue: No ]
    To compare change in glucose tolerance, independent of weight loss, between obese, diabetic participants who undergo gastric bypass or gastric banding.


Secondary Outcome Measures:
  • change in glucose tolerance before and after a GLP-1 receptor blocker is administered [ Time Frame: after 10% of body weight is lost (expected 4 weeks after bypass and 12 weeks after banding) ] [ Designated as safety issue: No ]
    To determine if GLP-1 is responsible for improved glucose tolerance following gastric bypass.


Biospecimen Retention:   Samples Without DNA

Extra blood will be stored for the potential analysis of additional hormones.


Estimated Enrollment: 16
Study Start Date: April 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastric bypass, Gastric banding

Detailed Description:

Many diabetic patients who have Roux-en-Y gastric bypass (RYGB) have rapid improvements in their blood sugars within days of their surgery, even before they have lost much weight. It typically takes much longer for these improvements to occur after adjustable gastric banding (AGB), despite an equally low caloric intake. Changes in levels of hormones released by the small intestine as a consequence of the particular type of surgery may be an important factor in the rapid improvement of blood sugars. One of these hormones, glucagon-like peptide-1 (GLP-1), has an important effect on insulin secretion from the pancreas. This study seeks to determine whether changes in GLP-1 are responsible for the improvement in blood sugar after certain types of weight loss surgeries. In order to meet inclusion criteria, participants must have type 2 diabetes for less than 10 years and be approved by insurance to undergo RYGB or AGB at the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center. We will obtain several measurements of GLP-1 and other hormones that affect glucose levels during the three study visits: 1) Visit 1 (2-3 weeks before surgery); 2) Visit 2 (after 10% of body weight is lost); and 3) Visit 3 (5-10 days after Visit 2). To see if the improvement in blood sugar after surgery is due to changes in GLP-1, we will block its effect on insulin release by giving either salt water or a medication that blocks the activity of GLP-1 during the two visits that take place after surgery (Visits 2 and 3). Each visit will last for 4-6 hours and participants will be compensated for their time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with type 2 diabetes who are medically approved and have insurance approval to undergo gastric bypass or gastric banding at the University of Pennsylvania.

Criteria

Inclusion Criteria:

  • Male and female participants age 18 years or older with a body mass index greater than >35 kg/m2 but less than <60 kg/m2 who undergo gastric bypass or gastric banding at the University of Pennsylvania.
  • Type 2 diabetes (defined as a pre-existing diagnosis, the use of oral antidiabetic medications or insulin, or a fasting plasma glucose greater than or equal to > 126 mg/dl and confirmed by a oral glucose tolerance test)
  • Ability to provide written informed consent

Exclusion Criteria:

  • A diagnosis of type 1 diabetes
  • Daily insulin requirement exceeding 1 unit/kg/d
  • Poor preoperative glycemic control, as indicated by an HbA1c greater than 10.0%
  • Duration of diabetes greater than> 10 years
  • Pregnant women (or those who intend to become pregnant during the study period)
  • Women who are currently breastfeeding
  • Participants with moderate anemia (hemoglobin less than< 12 g/dl for men and less than< 11 g/dl for women)
  • Use of medications known to affect weight, including chronic oral or inhaled glucocorticoid use and the use of certain psychiatric medications (olanzepine, risperidone, and lithium)
  • history of any major active rheumatologic, pulmonary, dermatologic disease, or inflammatory conditions
  • oral history of positive HIV status
  • any major surgery in the past 3 months
  • regular use of alcoholic beverages (greater than 7 drinks/week)
  • prior reaction to human albumin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153438

Contacts
Contact: Marion L Vetter, MD, RD 215-746-5129 Marion.Vetter@uphs.upenn.edu

Locations
United States, Pennsylvania
Center for Weight and Eating Disorders, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marion Vetter, MD, RD    215-746-5129    marion.vetter@uphs.upenn.edu   
Contact: Scott Ritter, MS    215-746-3818    sritter@sas.upenn.edu   
Principal Investigator: Marion L Vetter, MD, RD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Marion L Vetter, MD, RD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Marion L. Vetter, MD, RD, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01153438     History of Changes
Other Study ID Numbers: 810104
Study First Received: June 28, 2010
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Diabetes
Obesity
Bariatric surgery
Gut hormones
Glucagon like peptide 1
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on August 20, 2014