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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who develop hypoglycemia in response to physical activity | Participant displays or reports symptoms of clinically significant hypoglycemia (neuroglycopenia or a venous glucose level of less than 54 mg/dL). | Baseline (pre-exercise), assessed up to 180 minutes after the initiation of physical activity. |
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Inclusion Criteria:
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:
Exclusion criteria:
There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
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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.
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|
| Heart rate variability |
Comparison of R-R interval in milliseconds to normative values |
| Measured once at baseline |
| Hypoglycemia symptom score using the Edinburgh Hypoglycemia Symptom Scale (EHSS) | 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. | At 60 minute time point, or termination of physical activity if earlier. |
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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