Factors Affecting Insulin After Gastric Bypass Surgery
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
Recruiting
Early Phase 1Interventional Study
Post BariatricsurgeryHypoglycemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Other
Participants needed
160 (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Who this trial is looking for
This trial is looking for patients who have had gastric bypass surgery and may have low blood sugar (hypoglycemia). Participants will help researchers understand how certain factors affect insulin release after their surgery.
Are You a Good Fit for This Trial?
Rules you outType 2 diabetes
You may be able to join if
I have low blood sugar with levels below 50 mg/dl after gastric bypass surgery.
I am an asymptomatic person who has had bariatric surgery.
I am a healthy non-surgical patient with no personal history of diabetes.
I can visit the clinical research center at Cedars-Sinai Medical Center.
You may not be able to join if
I have active heart, lung, liver, gastrointestinal, or kidney disease.
I cannot give consent to participate.
I am pregnant.
I have high blood pressure or high cholesterol that is not under control.
I have significant anemia.
I have type 2 diabetes.
I have developed any serious medical or psychiatric illness recently.
I have gastric outlet obstruction or severe diarrhea if I had gastric bypass surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in pati…
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls.
Trial Locations
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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 at Cedars…
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 at 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 melitis; development of any serious medical or psychiatric illness during recruitment or studies;
* RYGB patients will also 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
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