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NCT Number: NCT02823665

The Effects of Bariatric Surgeries on Glucose Metabolism

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

South Texas Veterans Health Care System, San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exendin-(9-39)

Drug

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)

Atropine

Drug

A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.

Other names: Atropine sulfate

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Foster, MSN

CONTACT

[email protected]

210-450-8696

Marzieh Salehi, MD MS

CONTACT

[email protected]

210-567-6691

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2016
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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