The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia (NCT05560789) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia
United States3 participantsStarted 2023-01-03
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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);
✕. 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;
What they're measuring
1
Plasma glucose levels in response to physical activity
Timeframe: 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.
2
Insulin levels in response to physical activity
Timeframe: 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).
3
Glucagon levels in response to physical activity
Timeframe: 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).
4
Glucagon like peptide-1 (GLP-1) levels in response to physical activity
Timeframe: 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).