What side effects are associated with this type of intervention?

Structured exercise, as a treatment for Post-Bariatric Hypoglycemia (PBH), may lead to hypoglycemia during or after physical activity due to impaired counterregulatory hormonal responses. General treatments for PBH, such as dietary modifications and medications, can also have side effects. Dietary changes might cause gastrointestinal discomfort, while medications like acarbose can lead to flatulence and diarrhea. Continuous glucose monitoring, another common approach, may cause skin irritation at the sensor site.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Post-Bariatric Hypoglycemia (PBH) mentioned in the provided context. The trial on structured exercise aims to evaluate the physiological response to exercise in individuals with PBH, but no related pharmacologic treatments or FDA approvals are detailed. Generally, management of PBH may involve dietary modifications, medications to manage blood glucose levels, and lifestyle interventions such as structured exercise.

What other types of research exist?

Promising alternatives to structured exercise for managing post-bariatric hypoglycemia in 2024 include dietary modifications such as frequent small meals with a focus on low glycemic index foods, pharmacological interventions like acarbose or diazoxide to manage blood sugar levels, and continuous glucose monitoring to better track and respond to hypoglycemic episodes.

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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.

Must not have

Known insulinoma

Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma(MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured once at baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial involves people who have low blood sugar after weight-loss surgery doing exercises without eating first. The study will see if their blood sugar drops and if their body responds correctly to this drop. The goal is to understand how exercise affects their glucose and hormone levels.

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.

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.

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 below

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I am between 18 and 60 years old.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with insulinoma.

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I or my family have a history of pheochromocytoma or related genetic disorders.

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I have advanced chronic kidney disease.

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I have had heart issues or have 2+ risk factors like diabetes, high blood pressure, high cholesterol, or I smoke.

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I am currently on medication with somatostatin or diazoxide.

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I am currently taking diabetes medication, but not acarbose or miglitol.

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I have had a stroke before.

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I have not donated blood in the last 2 months.

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I have a seizure disorder not caused by low blood sugar.

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I have an active cancer other than skin cancer.

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I am currently taking steroids in pill or injection form.

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I have had fainting spells not caused by low blood sugar or have a heart rhythm problem.

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I have a bleeding disorder, am on warfarin, or have low platelets.

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I have been diagnosed with moderate to severe heart failure.

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My liver tests are not within the normal range.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Heart rate

Hypoglycemia

Number of participants who develop hypoglycemia in response to physical activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Post-Bariatric Hypoglycemia (PBH) is often managed through structured exercise, which improves insulin sensitivity and enhances glucose uptake by muscles, helping to stabilize blood glucose levels. Exercise also modulates counterregulatory hormonal responses, which are typically impaired in PBH patients. This approach is significant as it offers a non-pharmacological method to reduce the frequency and severity of hypoglycemic episodes, improving overall patient outcomes.

Factors associated with successful weight loss after liraglutide treatment for obesity.Effect of Medical and Surgical Interventions on α-Cell Function in Dysglycemic Youth and Adults in the RISE Study.Study of postprandial lipaemia in type 2 diabetes mellitus: exenatide versus liraglutide.