The Effects of Bariatric Surgeries on Glucose Metabolism

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Recruiting

CT.gov ID

NCT02823665

Collaborator

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

200

Enrollment

Locations

Arms

109

Duration (Months)

100

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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 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

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 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Diabetes Institute - University Health System	San Antonio	Texas	United States	78207
2	South Texas Veterans Health Care System	San Antonio	Texas	United States	78229