The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoglycemia
- Sponsor
- Joslin Diabetes Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Glucagon levels in response to physical activity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •Initial general screening will be performed during an initial phone or in person visit (e.g. during a clinical visit). Individuals who appear to meet criteria will be invited for a screening visit, when a detailed history and physical exam will be performed by study clinicians. Inclusion and exclusion criteria will be reviewed after the visit to determine study eligibility.
- •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:
- •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;
Outcomes
Primary Outcomes
Glucagon levels in response to physical activity
Time Frame: 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).
Area under the curve for glucagon levels will be analyzed. Glucagon levels will be measured in venous blood obtained through the intravenous catheter.
Glucagon like peptide-1 (GLP-1) levels in response to physical activity
Time Frame: 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).
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.
Plasma glucose levels in response to physical activity
Time Frame: 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.
Area under the curve for glucose levels will be analyzed. Plasma glucose will be measured at baseline, during and after physical activity.
Insulin levels in response to physical activity
Time Frame: 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).
Area under the curve for insulin levels will be analyzed. Insulin levels will be measured in venous blood obtained through the intravenous catheter.
Secondary Outcomes
- Heart rate variability(Measured once at baseline)
- 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.)
- Hypoglycemia symptom score using the Edinburgh Hypoglycemia Symptom Scale (EHSS)(At 60 minute time point, or termination of physical activity if earlier.)