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New treatment option for Post Bariatricsurgery
Official title Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
ClinicalTrials.gov ID: NCT00992901
What this study is testing
What is Exendin-(9-39)?
Exendin-(9-39) is an investigational medicine, being studied as a potential treatment for post bariatricsurgery.
Also referred to as No other name for Exendin-(9-39).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
- people must physically be able to come to our clinical research center at Cedars-Sinai Medical Center
You likely can't join if
- Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high...
- 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 people 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)
See the full eligibility 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
- people must physically be able to come to our clinical research center at Cedars-Sinai Medical Center
- 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...
- 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.