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

NCT01153438 | Completed DMC

• 1 other identifier: 810104
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 2 Diabetes; Obesity; Bariatric Surgery

Keywords

Diabetes; Obesity; Bariatric surgery; Gut hormones; Glucagon like peptide 1; Insulin

Outcome Measures

Primary Outcomes (1)

• change in glucose tolerance after surgery (measured by glucose area under the curve)

  To compare change in glucose tolerance, independent of weight loss, between obese, diabetic participants who undergo gastric bypass or gastric banding.

  after surgery when 10% of initial body weight is lost (expected 4 weeks after bypass and 12 weeks after banding)

Secondary Outcomes (1)

• change in glucose tolerance before and after a GLP-1 receptor blocker is administered

  after 10% of body weight is lost (expected 4 weeks after bypass and 12 weeks after banding)

Study Arms (1)

Gastric bypass, Gastric banding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for Weight and Eating Disorders, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Marion L Vetter, MD, RD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)