The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia

NCT05560789 | Completed

• 1 other identifier: 00000190
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to evaluate the magnitude of changes in glucose and hormone levels in response to structured exercise in the fasting state in individuals with post-bariatric hypoglycemia (PBH). This pilot study will assess the adequacy of a protocol to test the following hypotheses: (1) hypoglycemia will develop in individuals with PBH in response to exercise; (2) counterregulatory hormonal responses to hypoglycemia during exercise are impaired in individuals with PBH.

Conditions

Hypoglycemia; Roux-en-Y Gastric Bypass; Post-bariatric Hypoglycemia; Physical Activity

Keywords

Post-bariatric hypoglycemia; Exercise; Physical activity; Hypoglycemia; Bariatric surgery

Outcome Measures

Primary Outcomes (4)

• Plasma glucose levels in response to physical activity

  Area under the curve for glucose levels will be analyzed. Plasma glucose will be measured at baseline, during and after physical activity.

  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.

• Insulin levels in response to physical activity

  Area under the curve for insulin levels will be analyzed. Insulin levels will be measured in venous blood obtained through the intravenous catheter.

  Insulin levels are measured at baseline (pre-exercise), 15, 30, 45, 60, 90 and 120 minutes, as well as at the time of hypoglycemia (up to the 120 minute time point, should it occur).

• Glucagon levels in response to physical activity

  Area under the curve for glucagon levels will be analyzed. Glucagon levels will be measured in venous blood obtained through the intravenous catheter.

  Glucagon levels are measured at baseline (pre-exercise), 15, 30, 45, 60, 90 and 120 minutes, as well as at the time of hypoglycemia (up to the 120 minute timepoint should it occur).

• Glucagon like peptide-1 (GLP-1) levels in response to physical activity

  Area under the curve for GLP-1 levels will be analyzed. GLP-1 levels will be measured in venous blood obtained through the intravenous catheter.

  GLP-1 levels are measured at baseline (pre-exercise), 15, 30, 45, 60, 90 and 120 minutes, as well as at the time of hypoglycemia (up to the 120 time point should it occur).

Secondary Outcomes (3)

• Number of participants who develop hypoglycemia in response to physical activity

  Baseline (pre-exercise), assessed up to 180 minutes after the initiation of physical activity.

• Heart rate variability

  Measured once at baseline

• Hypoglycemia symptom score using the Edinburgh Hypoglycemia Symptom Scale (EHSS)

  At 60 minute time point, or termination of physical activity if earlier.

Study Arms (1)

Participants with Post-bariatric Hypoglycemia Performing Structured Physical Activity

EXPERIMENTAL

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.

Behavioral: Physical activity (cycling on a stationary bicycle ergometer or walking on a treadmill)

Interventions

Physical activity (cycling on a stationary bicycle ergometer or walking on a treadmill) BEHAVIORAL

At time 0, exercise will be initiated and intensity will be increased at 2 minute intervals to achieve low intensity for 30 minutes (as defined by heart rate target 50-55% of maximum heart rate determined as 220-age). Next, intensity will be increased at 2 minute intervals until the heart rate target for moderate intensity exercise is achieved (55-65% of max heart rate), or the total duration of exercise of up to 60 minutes is achieved.

Participants with Post-bariatric Hypoglycemia Performing Structured Physical Activity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
• Age 18-60 years of age, inclusive, at screening.
• Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

You may not qualify if:

• Males or females diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
• Age 18-60 years of age, inclusive, at screening.
• Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
• Inability to exercise or medical contraindication to exercise;
• Documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
• Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
• Hepatic disease, including serum alanine transaminase (ALT) or aspartate transferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
• Congestive heart failure, New York Heart Association (NYHA) class II, III or IV;
• History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use;
• History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia;
• Concurrent administration of β-blocker therapy;
• History of a cerebrovascular accident;
• Seizure disorder (other than with suspect or documented hypoglycemia);
• Active treatment with any diabetes medications except for acarbose and miglitol;
• Active treatment with a somatostatin analogue (both long and short acting) or diazoxide;

Sponsors & Collaborators

• Joslin Diabetes Center: lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hypoglycemia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will assess glucose and hormone responses (insulin, glucagon, GLP-1) during structured exercise on a stationary bicycle ergometer or on a treadmill, up to a duration of 60 minutes, in individuals with a history of post-bariatric hypoglycemia.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 29, 2022
• Study Start: January 3, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

US (1)