The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia

Physical Activity Clinical Trial

Official title:

The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560789
• Other study ID #: 00000190
• Status: Completed
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: April 2024
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 exclusion criteria will be reviewed after the visit to determine study eligibility.

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:

1. Inability to exercise or medical contraindication to exercise;

2. Documented hypoglycemia occurring in the fasting state (> 12 hours fast);

3. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);

4. 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;

5. Congestive heart failure, New York Heart Association (NYHA) class II, III or IV;

6. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use;

7. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia;

8. Concurrent administration of ß-blocker therapy;

9. History of a cerebrovascular accident;

10. Seizure disorder (other than with suspect or documented hypoglycemia);

11. Active treatment with any diabetes medications except for acarbose and miglitol;

12. Active treatment with a somatostatin analogue (both long and short acting) or diazoxide;

13. Active malignancy, except basal cell or squamous cell skin cancers;

14. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma(MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);

15. Known insulinoma;

16. Major surgical operation within 30 days prior to screening;

17. Hematocrit < 33% (women) or <36% (men);

18. Bleeding disorder, treatment with warfarin, or platelet count <50,000;

19. Blood donation (1 pint of whole blood) within the past 2 months;

20. Active alcohol abuse or substance abuse;

21. Current administration of oral or parenteral corticosteroids;

22. Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intra-uterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence;

23. Use of an investigational drug within 30 days prior to screening.

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.

Related Conditions & MeSH terms

• Hypoglycemia
• Physical Activity
• Post-bariatric Hypoglycemia
• Roux-en-Y Gastric Bypass

Intervention

Behavioral:
• Physical 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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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).
Primary	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).
Primary	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).
Secondary	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.
Secondary	Heart rate variability	Comparison of R-R interval in milliseconds to normative values	Measured once at baseline
Secondary	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.