Clinical trial NCT02823665: The Effects of Bariatric Surgeries on Glucose Metabolism
Official title: The Effects of Bariatric Surgeries on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Post Bariatric Surgery
Gastric Bypass
Sleeve Gastrectomy
Hypoglycemia After Gastric Bypass
Keywords: gastric bypass surgery
Hypoglycemia
sleeve gastrectomy
glucose tolerance
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Insulin levels measured after nutrient ingestion
timeFrame: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas Diabetes Institute - University Health System
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Marzieh Salehi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: