Mechanisms of Hypoglycemia in Patients Without Diabetes
NCT ID: NCT04428723
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
33 participants
OBSERVATIONAL
2020-08-11
2025-06-30
Brief Summary
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Detailed Description
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The current study aims to:
1. more fully characterize clinical history and demographics in patients with diverse forms of hypoglycemia by creating and analyzing a patient database;
2. for a subset of patients, characterize metabolic and hormonal responses to a standard meal;
3. analyze DNA variants in individuals with hypoglycemia;
4. analyze differences in the intestinal microbiome in individuals with hypoglycemia.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Hypoglycemia, no upper gastrointestinal (GI) surgery
Males or females with hypoglycemia with neuroglycopenia, but no history of upper GI surgery, diabetes or prediabetes
Entry of demographic and medical history data into a deidentified database
Entry into repository for analysis.
Blood sample for DNA analysis
Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls.
Stool sample for microbiome analysis
Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.
Mixed meal tolerance test
For a subset of participants: After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.
Continuous glucose monitoring
A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.
activity monitor
The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
Hypoglycemia, with history of upper GI surgery
Males or females with hypoglycemia with neuroglycopenia, with history of upper GI surgery
Entry of demographic and medical history data into a deidentified database
Entry into repository for analysis.
Blood sample for DNA analysis
Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls.
Stool sample for microbiome analysis
Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.
Mixed meal tolerance test
For a subset of participants: After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.
Continuous glucose monitoring
A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.
activity monitor
The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
Controls, without hypoglycemia or upper GI surgery
Males or females with no history of upper gastrointestinal surgery, hypoglycemia, or diabetes.
Entry of demographic and medical history data into a deidentified database
Entry into repository for analysis.
Blood sample for DNA analysis
Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls.
Stool sample for microbiome analysis
Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.
Mixed meal tolerance test
For a subset of participants: After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.
Continuous glucose monitoring
A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.
activity monitor
The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
Interventions
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Entry of demographic and medical history data into a deidentified database
Entry into repository for analysis.
Blood sample for DNA analysis
Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls.
Stool sample for microbiome analysis
Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.
Mixed meal tolerance test
For a subset of participants: After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.
Continuous glucose monitoring
A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.
activity monitor
The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For hypoglycemia group with history of upper gastrointestinal surgery: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia.
3. For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes.
4. Age 18-70 years of age, inclusive, at screening.
5. Willingness to provide informed consent and attend one study visit, with option to attend a second visit with mixed meal test, and follow all study procedures
Exclusion Criteria
2. Known insulinoma, gastrinoma, or other neuroendocrine tumor;
1. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
2. Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (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;
3. Congestive heart failure, New York Hear Association (NYHA) class II, III or IV;
4. 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;
5. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia;
6. Concurrent administration of β-blocker therapy;
7. History of a cerebrovascular accident;
8. Seizure disorder (other than with suspect or documented hypoglycemia);
9. Active malignancy, except basal cell or squamous cell skin cancers;
10. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
11. Major surgical operation within 30 days prior to screening;
12. Hematocrit \< 33% (women) or \<36% (men);
13. Bleeding disorder, treatment with warfarin, or platelet count \<50,000;
14. Blood donation (1 pint of whole blood) within the past 2 months;
15. Active alcohol abuse or substance abuse;
16. Current administration of oral or parenteral corticosteroids;
17. 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 intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
18. 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Joslin Diabetes Center
OTHER
Responsible Party
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Principal Investigators
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Mary Elizabeth Patti, MD
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Locations
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Joslin Diabetes Center
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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recruitment website with contact information
Other Identifiers
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00000095
Identifier Type: -
Identifier Source: org_study_id