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Physical Activity for Post-Bariatric Hypoglycemia
N/A
Waitlist Available
Research Sponsored by Joslin Diabetes Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-60 years of age, inclusive, at screening
Age 18-60 years of age, inclusive, at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured once at baseline
Awards & highlights
Study Summary
This trial will help researchers understand how structured exercise affects glucose and hormone levels in people with post-bariatric hypoglycemia, a condition that can cause low blood sugar.
Who is the study for?
This trial is for adults aged 18-60 with post-bariatric hypoglycemia unresponsive to diet changes and acarbose therapy. Participants must be able to exercise, not have a history of certain medical conditions like active cancer (except some skin cancers), major recent surgery, or severe kidney disease, and agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests how structured physical activity (like cycling or walking on a treadmill) affects blood sugar and hormone levels in fasting individuals with post-bariatric hypoglycemia. It aims to see if exercise induces low blood sugar and whether hormonal responses during exercise are different in these individuals.See study design
What are the potential side effects?
Since the intervention involves physical activity, potential side effects may include typical exercise-related issues such as muscle soreness, fatigue, joint pain, or more serious events related to low blood sugar episodes triggered by exertion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ blood samples will be collected for measurement of plasma glucose at baseline (pre-exercise), 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, and 180 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples will be collected for measurement of plasma glucose at baseline (pre-exercise), 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, and 180 minutes.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucagon levels in response to physical activity
Glucagon like peptide-1 (GLP-1) levels in response to physical activity
Insulin levels in response to physical activity
+1 moreSecondary outcome measures
Heart rate
Hypoglycemia
Number of participants who develop hypoglycemia in response to physical activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Post-bariatric Hypoglycemia Performing Structured Physical ActivityExperimental Treatment1 Intervention
Individuals with a confirmed diagnosis of post-bariatric hypoglycemia will perform structured physical activity by cycling on a stationary bicycle ergometer or on a treadmill.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical activity (cycling on a stationary bicycle ergometer or walking on a treadmill)
2023
N/A
~10
Find a Location
Who is running the clinical trial?
Joslin Diabetes CenterLead Sponsor
96 Previous Clinical Trials
26,570 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with insulinoma.You cannot do physical activity or your doctor advises against it.I have low blood sugar after weight loss surgery that diet and acarbose can't control.I am currently taking β-blocker medication.I am between 18 and 60 years old.I or my family have a history of pheochromocytoma or related genetic disorders.Your hematocrit level is below 33% if you're a woman, or below 36% if you're a man.I have advanced chronic kidney disease.I am currently on medication with somatostatin or diazoxide.I have low blood sugar after weight loss surgery that hasn't improved with diet or medication.I have had heart issues or have 2+ risk factors like diabetes, high blood pressure, high cholesterol, or I smoke.I am currently taking diabetes medication, but not acarbose or miglitol.I have had a stroke before.I have not donated blood in the last 2 months.I have a seizure disorder not caused by low blood sugar.You are currently misusing alcohol or drugs.You have a record of low blood sugar when you haven't eaten for more than 12 hours.I have not had major surgery in the last 30 days.I have an active cancer other than skin cancer.I am currently taking steroids in pill or injection form.I have had fainting spells not caused by low blood sugar or have a heart rhythm problem.I have a bleeding disorder, am on warfarin, or have low platelets.I have been diagnosed with moderate to severe heart failure.My liver tests are not within the normal range.You are willing to provide informed consent and follow all study procedures, including attending all scheduled visits.I am between 18 and 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Post-bariatric Hypoglycemia Performing Structured Physical Activity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacant positions that can be filled by prospective participants in this trial?
"Affirmative. Clinicaltrials.gov data verifies that this research effort, which was first launched on November 30th 2022 is currently recruiting individuals for participation. There are 4 patients needed from a single clinical site."
Answered by AI
Do people below the age of eighteen qualify for participation in this research project?
"This medical trial has a lower age limit of 18 and an upper threshold of 60, in accordance with the established eligibility requirements."
Answered by AI
How many participants have been enrolled in this research project?
"Affirmative. As per clinicaltrials.gov, this medical study is actively looking for volunteers and was initially posted on November 30th 2022; the most recent update occurred on November 16th of the same year. The trial requires 4 individuals from one location to participate."
Answered by AI
Am I an eligible candidate for this research project?
"This trial is recruiting 4 participants aged 18 to 60 who have hypoglycemia. Eligibility requirements additionally include: gender, diagnosis of post-bariatric hypoglycemia with prior episodes of neuroglycopenia unresponsive to dietary intervention and acarbose therapy at the maximally tolerated dose, willingness to consent and adhere to all study procedures including attending each visit."
Answered by AI
Who else is applying?
What site did they apply to?
Joslin Diabetes Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Joslin Diabetes Center: < 48 hours
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