Hypoglycemia, Physical Activity, Post-bariatric Hypoglycemia, Roux-en-Y Gastric Bypass
Conditions
Keywords
Post-bariatric hypoglycemia, Exercise, Physical activity, Hypoglycemia, Bariatric surgery
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.
Interventions
BEHAVIORALPhysical 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
Joslin Diabetes Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Age 18-60 years of age, inclusive, at screening. 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose levels in response to 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. | 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 | 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. |
| Glucagon levels in response to physical activity | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | Measured once at baseline | Comparison of R-R interval in milliseconds to normative values |
| Hypoglycemia symptom score using the Edinburgh Hypoglycemia Symptom Scale (EHSS) | At 60 minute time point, or termination of physical activity if earlier. | The total EHSS score will be compared between participants. The EHSS total score range is from 18 (which signifies no symptoms of hypoglycemia are present) to 126 (which signifies that the participant has all of assessed for symptoms qualified as very severe). Thus a higher score indicates the presence of both a higher number and/or greater severity of symptoms. |
| 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. | Participant displays or reports symptoms of clinically significant hypoglycemia (neuroglycopenia or a venous glucose level of less than 54 mg/dL). |
Countries
United States
Outcome results
None listed