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The Effects of Bariatric Surgeries on Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT02823665
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post Bariatric Surgery Gastric Bypass Sleeve Gastrectomy Hypoglycemia After Gastric Bypass Drug: Exendin-(9-39) Drug: Atropine Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Effects of Bariatric Surgeries on Glucose Metabolism
Study Start Date : July 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Atropine sulfate




Primary Outcome Measures :
  1. Insulin levels measured after nutrient ingestion [ Time Frame: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823665


Contacts
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Contact: Marzieh Salehi, MD MS 210-567-6691 salehi@uthscsa.edu
Contact: Andrea Hansis-Diarte 210-567-6691 hansisdiarte@uthscsa.edu

Locations
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United States, Texas
South Texas Veterans Health Care System Recruiting
San Antonio, Texas, United States, 78229
Contact: Andrea Hansis-Diarte    210-567-6691    hansisdiarte@uthscsa.edu   
Principal Investigator: Marzieh Salehi, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Marzieh Salehi, MD, MS The University of Texas Health Science Center at San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02823665     History of Changes
Other Study ID Numbers: 20180070H
1R01DK105379-01 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Texas Health Science Center at San Antonio:
gastric bypass surgery
Hypoglycemia
sleeve gastrectomy
glucose tolerance

Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Atropine
Hypoglycemic Agents
Physiological Effects of Drugs
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action