The Effects of Bariatric Surgeries on Glucose Metabolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exendin-(9-39), Atropine.
- Who it may be relevant to
- Registry conditions: Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - Drug Atropine
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
Primary outcome measures
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 2 centers
- Texas Diabetes Institute - University Health System — San Antonio
- South Texas Veterans Health Care System — San Antonio
Identifiers
NCT: NCT02823665 · 20180070H · 1R01DK105379-01