HypoglycemiaNCT03385707
Hypoglycemia and the Gut Microbiome
An observational study of Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
This study is designed to evaluate individuals who are currently experiencing symptoms of hypoglycemia, in order to discern correlations between microbiome composition and patterns of postprandial glycemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoglycemia
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who experience hypoglycemia after bariatric or other upper gastrointestinal surgery or those with reactive hypoglycemia in the absence of surgery.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to evaluate individuals who are currently experiencing symptoms of hypoglycemia, in order to discern correlations between microbiome composition and patterns of postprandial glycemia.
Read the detailed description
Recent studies have shown that analysis of the gastrointestinal microbiome can be used to predict glycemic response to dietary intake. Specifically, integrative analysis of dietary consumption, anthropometrics, physical activity and gut microbiota composition can be used to predict postprandial glycemic excursions. The investigators hypothesize that individualized assessment of glycemic responses to food, together with analysis of the gut microbiome, will allow the design of a personalized dietary approach to minimize glycemic excursions for patients with post-bariatric and other forms of largely postprandial hypoglycemia. Identification of factors predictive of glycemic excursions and subsequent hypoglycemia may ultimately allow individuals to tailor their diet towards foods which would not induce hypersecretion of insulin and subsequent hypoglycemia.
- Conditions
- Hypoglycemia
- Keywords
- Post-bariatric hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Analysis of cumulative duration of hypoglycemia
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.
Measured: 2 weeks
Secondary outcomes (4)
Analysis of frequency of glycemic excursions
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.
Measured: 2 weeks
Impact of activity on glycemic patterns in post-bariatric hypoglycemia
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.
Measured: 2 weeks
Impact of diet on glycemic patterns in post-bariatric hypoglycemia
Dietary information will be transcribed and recorded from participants' food diaries. Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.
Measured: 2 weeks
Analysis of microbiome in individuals with post-bariatric hypoglycemia
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start7 Feb 2019
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary E Patti, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385707
- Sponsor's protocol ID
- 2017-28
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26701701Mulla 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.
PubMed 28868615Suhl 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.
PubMed 28392017
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT03385707
- Acronym / sponsor ID
- 2017-28
- Conditions
- Hypoglycemia
- Keywords
- Post-bariatric hypoglycemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate individuals who are currently experiencing symptoms of hypoglycemia, in order to discern correlations between microbiome composition and patterns of postprandial glycemia.
Detailed description
Recent studies have shown that analysis of the gastrointestinal microbiome can be used to predict glycemic response to dietary intake. Specifically, integrative analysis of dietary consumption, anthropometrics, physical activity and gut microbiota composition can be used to predict postprandial glycemic excursions. The investigators hypothesize that individualized assessment of glycemic responses to food, together with analysis of the gut microbiome, will allow the design of a personalized dietary approach to minimize glycemic excursions for patients with post-bariatric and other forms of largely postprandial hypoglycemia. Identification of factors predictive of glycemic excursions and subsequent hypoglycemia may ultimately allow individuals to tailor their diet towards foods which would not induce hypersecretion of insulin and subsequent hypoglycemia.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who experience hypoglycemia after bariatric or other upper gastrointestinal surgery or those with reactive hypoglycemia in the absence of surgery.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Analysis of frequency of glycemic excursions
Time frame: 2 weeks
Impact of activity on glycemic patterns in post-bariatric hypoglycemia
Time frame: 2 weeks
Impact of diet on glycemic patterns in post-bariatric hypoglycemia
Time frame: 2 weeks
Analysis of microbiome in individuals with post-bariatric hypoglycemia
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 26701701Patti 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.
- Background: PubMed 28868615Mulla 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.
- Background: PubMed 28392017Suhl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Patti, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of cumulative duration of hypoglycemia (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385707, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.