Purpose

The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
  • Asymptomatic individuals with bariatric surgery
  • Healthy non-surgical patients with no personal history of diabetes
  • Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center

Exclusion Criteria

  • Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
  • RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
  • Healthy non-surgical patients with personal history of diabetes

For administration of atropine, the following exclusions also apply:

- History of glaucoma

- Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia

- Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)

- Myasthenia gravis

- Brain pathology

- Enlarged prostate in men

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Exendin-(9-39)
To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
  • Drug: Exendin-(9-39)
    A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
    Other names:
    • no other name for Exendin-(9-39)
Experimental
Atropine
to evaluate the effect of neural activation on insulin secretion and glucose metabolism
  • Drug: Atropine
    A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
    Other names:
    • Atropine sulfate

Recruiting Locations

South Texas Veterans Health Care System
San Antonio, Texas 78229
Contact:
Andrea Hansis-Diarte
210-567-6691
hansisdiarte@uthscsa.edu

Texas Diabetes Institute - University Health System
San Antonio, Texas 78207
Contact:
Andrea Hansis-Diarte, MPh
210-567-3208
hansisdiarte@uthscsa.edu

More Details

NCT ID
NCT02823665
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Marzieh Salehi, MD MS
210-567-6691
salehi@uthscsa.edu

Detailed Description

The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures.

Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.