The Effects of Bariatric Surgeries on Glucose Metabolism

The University of Texas System (UT)

Status and phase: Enrolling; Early Phase 1

Conditions: Post Bariatric Surgery; Gastric Bypass; Sleeve Gastrectomy; Hypoglycemia After Gastric Bypass

Treatments: Drug: Exendin-(9-39); Drug: Atropine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02823665

20180070H

1R01DK105379-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Exendin-(9-39)

Experimental group

Description:

To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

Treatment:

Drug: Exendin-(9-39)

Atropine

Experimental group

Description:

to evaluate the effect of neural activation on insulin secretion and glucose metabolism

Treatment:

Drug: Atropine