Hypoglycemia and the Gut Microbiome
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mary E Patti, MD
- Phone Number: (617) 309-2635
- Email: maryelizabeth.patti@joslin.harvard.edu
Study Contact Backup
- Name: Lauren N Richardson, BS
- Phone Number: (617) 309-4463
- Email: lauren.richardson@joslin.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Males or females diagnosed with ongoing post-bariatric, post-gastric surgery or other forms of postprandial hypoglycemia with prior episodes of neuroglycopenia
- Age 18-65 years of age, inclusive, at screening.
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Exclusion Criteria
- Documented hypoglycemia occurring in the fasting state (> 12 hours fast);
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- Hepatic disease, including serum alanine aminotransferase (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;
- Congestive heart failure, New York Heart Association (NYHA) class II, III or IV;
- 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.
- History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
- Concurrent administration of β-blocker therapy;
- History of a cerebrovascular accident;
- Seizure disorder (other than with suspect or documented hypoglycemia);
- Active treatment with any diabetes medications except for acarbose;
- Active treatment with octreotide or diazoxide;
- Active malignancy, except basal cell or squamous cell skin cancers;
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
- Known insulinoma;
- Major surgical operation within 30 days prior to screening;
- Hematocrit < 33%;
- Bleeding disorder, treatment with warfarin, or platelet count <50,000;
- Blood donation (1 pint of whole blood) within the past 2 months;
- Active alcohol abuse or substance abuse;
- Current administration of oral or parenteral corticosteroids;
- 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.
- Use of an investigational drug within 30 days prior to screening.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
CGM and Microbiota
Participants will wear a Dexcom continuous glucose monitor (CGM) and activity monitor for two weeks.
They will not be aware of sensor glucose values.
A stool sample will be collected.
The investigators will evaluate relationships between patterns of postprandial glycemia, recorded by CGM, food intake, and microbiome composition.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of cumulative duration of hypoglycemia
Time Frame: 2 weeks
|
Duration of hypoglycemia will be assessed by: (1) the number of minutes per day with hypoglycemia, defined as sensor glucose <70 mg/dl, and (2) the number of minutes per day of severe hypoglycemia, defined as sensor glucose <55 mg/dl.
Data will be captured for the entire 24 hour period as well as day and night subsets.
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2 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of frequency of glycemic excursions
Time Frame: 2 weeks
|
Hypoglycemia frequency will be assessed by: (1) number of episodes of hypoglycemia, both moderate (55-70 mg/dl) and severe (<55 mg/dl), (2) number of episodes requiring assistance, and (4) number of episodes of hyperglycemia (>180 mg/dl).
All data will be averaged and reported as episodes per day.
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2 weeks
|
|
Impact of activity on glycemic patterns in post-bariatric hypoglycemia
Time Frame: 2 weeks
|
Activity measures (total step number per day) will be analyzed to determine relationship to changes in sensor glucose levels.
Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.
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2 weeks
|
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Impact of diet on glycemic patterns in post-bariatric hypoglycemia
Time Frame: 2 weeks
|
Dietary information will be transcribed and recorded from participants' food diaries.
Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.
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2 weeks
|
|
Analysis of microbiome in individuals with post-bariatric hypoglycemia
Time Frame: 2 weeks
|
Stool samples will be analyzed to determine microbiome community by 18S sequencing.
Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Mary E Patti, MD, Joslin Diabetes Center
Publications and helpful links
General Publications
- Patti ME, Goldfine AB. The rollercoaster of post-bariatric hypoglycaemia. Lancet Diabetes Endocrinol. 2016 Feb;4(2):94-6. doi: 10.1016/S2213-8587(15)00460-X. Epub 2015 Dec 15. No abstract available.
- Mulla CM, Middelbeek RJW, Patti ME. Mechanisms of weight loss and improved metabolism following bariatric surgery. Ann N Y Acad Sci. 2018 Jan;1411(1):53-64. doi: 10.1111/nyas.13409. Epub 2017 Sep 3.
- Suhl E, Anderson-Haynes SE, Mulla C, Patti ME. Medical nutrition therapy for post-bariatric hypoglycemia: practical insights. Surg Obes Relat Dis. 2017 May;13(5):888-896. doi: 10.1016/j.soard.2017.01.025. Epub 2017 Jan 16.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2017-28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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