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

NCT05560789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-04-08

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

  • Joslin Diabetes Center

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2024-03-22
Completion
2024-03-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560789 on ClinicalTrials.gov