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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
3
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.
Joslin Diabetes Center
Boston, Massachusetts, United States
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.
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.
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.
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).
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.
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).
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.
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).
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).
Time frame: Baseline (pre-exercise), assessed up to 180 minutes after the initiation of physical activity.
Heart rate variability
Comparison of R-R interval in milliseconds to normative values
Time frame: 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.
Time frame: At 60 minute time point, or termination of physical activity if earlier.
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