HypoglycemiaNCT04428723
Mechanisms of Hypoglycemia in Patients Without Diabetes
An observational study of Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The goal of this study is to identify physiologic and molecular mechanisms that underlie hypoglycemia in the absence of diabetes (or medications that can cause hypoglycemia) and to investigate potential genetic and microbiome differences which contribute to hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Entry of demographic and medical history data into a deidentified database, Blood sample for DNA analysis and Stool sample for microbiome analysis
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to Dec 2026
- How long will I take part?
- 3 Weeks
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 groups: (1) patients with hypoglycemia, but without a history of bariatric or other gastrointestinal surgery, recruited from the Joslin Hypoglycemia Clinic, (2) patients with hypoglycemia and history of upper gastrointestinal surgery, recruited from the Joslin Hypoglycemia Clinic,(3) controls without hypoglycemia or surgery, recruited by local advertisement or from family members of patients with hypoglycemia. We plan to enroll patients with hypoglycemia continuously over the next 5 years.
Who may be able to join
- For hypoglycemia group without a history of bariatric surgery: Males or females diagnosed with hypoglycemia with prior episodes of neuroglycopenia.
- For hypoglycemia group with history of upper gastrointestinal surgery: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia.
- For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes.
- Age 18-70 years of age, inclusive, at screening.
- 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
Who cannot join
- Active treatment with any diabetes medications except for acarbose;
- Known insulinoma, gastrinoma, or other neuroendocrine tumor;
- Additional exclusion criteria for those participating in optional Visit 2 (meal testing):
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- 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;
- Congestive heart failure, New York Hear Association (NYHA) class II, III or IV;
Show all 22Show fewer
- 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 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);
- Major surgical operation within 30 days prior to screening;
- Hematocrit < 33% (women) or <36% (men);
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to identify physiologic and molecular mechanisms that underlie hypoglycemia in the absence of diabetes (or medications that can cause hypoglycemia) and to investigate potential genetic and microbiome differences which contribute to hypoglycemia. We will test the hypothesis that hypoglycemia in the absence of diabetes is linked to genetic variation or the microbiome, and identify whether additional medical history or diagnoses are enriched in the population of patients with hypoglycemia.
Read the detailed description
Although there are several conditions which have been identified that cause, or contribute to hypoglycemia, diagnosis can be challenging, as the physiologic, and molecular mechanisms are incompletely understood. Additionally, treatment options are relatively limited, and often incompletely effective and/or not well tolerated. Investigating the causative factors and mechanisms of hypoglycemia is important therefore in improving our understanding in order to develop new and more effective approaches to treatment.
The current study aims to:
- more fully characterize clinical history and demographics in patients with diverse forms of hypoglycemia by creating and analyzing a patient database;
- for a subset of patients, characterize metabolic and hormonal responses to a standard meal;
- analyze DNA variants in individuals with hypoglycemia;
- analyze differences in the intestinal microbiome in individuals with hypoglycemia.
- Conditions
- Hypoglycemia
- Being tested
- Entry of demographic and medical history data into a deidentified database, Blood sample for DNA analysis, Stool sample for microbiome analysis, Mixed meal tolerance test, Continuous glucose monitoring
- Keywords
- Microbiome, DNA, Hormones, Genetics
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entry of demographic and medical history data into a deidentified databaseOther
Entry into repository for analysis.
Blood sample for DNA analysisGenetic
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 analysisDiagnostic test
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 testDiagnostic test
Also called Meal Testing
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 monitoringDiagnostic test
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 monitorDiagnostic test
The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglycemia, no upper gastrointestinal (GI) surgery | Males or females with hypoglycemia with neuroglycopenia, but no history of upper GI surgery, diabetes or prediabetes Receives: Other: Entry of demographic and medical history data into a deidentified database; Genetic: Blood sample for DNA analysis; Diagnostic Test: Stool sample for microbiome analysis; Diagnostic Test: Mixed meal tolerance test; Diagnostic Test: Continuous glucose monitoring; Diagnostic Test: activity monitor | |
| Hypoglycemia, with history of upper GI surgery | Males or females with hypoglycemia with neuroglycopenia, with history of upper GI surgery Receives: Other: Entry of demographic and medical history data into a deidentified database; Genetic: Blood sample for DNA analysis; Diagnostic Test: Stool sample for microbiome analysis; Diagnostic Test: Mixed meal tolerance test; Diagnostic Test: Continuous glucose monitoring; Diagnostic Test: activity monitor | |
| Controls, without hypoglycemia or upper GI surgery | Males or females with no history of upper gastrointestinal surgery, hypoglycemia, or diabetes. Receives: Other: Entry of demographic and medical history data into a deidentified database; Genetic: Blood sample for DNA analysis; Diagnostic Test: Stool sample for microbiome analysis; Diagnostic Test: Mixed meal tolerance test; Diagnostic Test: Continuous glucose monitoring; Diagnostic Test: activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Entry of medical history data into a deidentified database.
Medical history data will be entered into RedCap for analysis.
Measured: March 2020 through March 2025
Entry of physical exam data into a deidentified database.
Pertinent physical exam data will be entered into RedCap for analysis.
Measured: March 2020 through March 2025
Entry of laboratory data into a deidentified database.
Laboratory data will be entered into RedCap for analysis.
Measured: March 2020 through March 2025
Entry of demographic data into a deidentified database.
Demographic data will be entered into RedCap for analysis.
Measured: March 2020 through March 2025
Analysis of participant demographics and medical history, comparing the 3 study groups.
Demographic and medical history data will be summarized in RedCap and compared between groups using ANOVA or chi-square testing, depending on the variable analyzed.
Measured: March 2025
Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing patients with hypoglycemia (both surgical and non-surgical) and healthy controls.
Sequence variants identified during targeted resequencing will be summarized and prevalence will be compared between groups and with population databases. Depending on results of targeted resequencing, additional expanded genotyping may be performed.
Measured: March 2025
Analysis of microbiome, comparing study groups.
Microbiome will be characterized by sequencing to obtain metagenomic data and pathway analysis; all data will be adjusted for multiple comparisons.
Measured: March 2025
Analysis of glucose patterns during masked continuous glucose monitoring (CGM), including time in range, time in hypoglycemia, time in hyperglycemia, comparing the study groups.
For a subset of participants who consent to participate in optional Visit 2, CGM data will be analyzed to assess mean, median, peak, and nadir sensor glucose values, glycemic variability (GV), severity and length of hypoglycemia (% time glucose <70, <60, <54 mg/dL), and number and duration of severe hypoglycemia (sensor glucose <54, duration >15 minutes) will be quantified. Metrics will be assessed over 24 hours and during daytime (6 AM to midnight) and nighttime (midnight to 6 AM) independently.
Measured: March 2025
Analysis of metabolic responses during mixed meal testing.
For a subset of participants who consent to participate in optional Visit 2, magnitude of hypoglycemia will be correlated with metabolite levels during meal testing. Metabolites will be measured at set time points after the start of the mixed meal. Linear mixed effects modeling will be utilized to identify group- and time-dependent differences in metabolic responses. Data will be checked to ensure variables conform to assumptions of the analysis. Sensitivity analysis will determine whether missing data are randomly associated with clinical or experimental phenotypes, and assess the impact of missing data on conclusions. The relationship between clinical and metabolic variables will be analyzed using Pearson correlation, and adjusted for multiple comparisons using Benjamini-Hochberg testing.
Measured: March 2025
Analysis of hormonal responses during mixed meal testing.
For a subset of participants who consent to participate in optional Visit 2, magnitude of hypoglycemia will be correlated with hormone levels during meal testing. Counterregulatory hormones will be measured at set time points after the start of the mixed meal. Linear mixed effects modeling will be utilized to identify group- and time-dependent differences in counterregulatory hormone responses. Data will be checked to ensure variables conform to assumptions of the analysis. Sensitivity analysis will determine whether missing data are randomly associated with clinical or experimental phenotypes, and assess the impact of missing data on conclusions. The relationship between clinical and hormonal variables will be analyzed using Pearson correlation, and adjusted for multiple comparisons using Benjamini-Hochberg testing.
Measured: March 2025
Secondary outcomes (4)
Relationship between metabolic responses and magnitude of hypoglycemia as determined by CGM.
This is for a subset of participants (non-surgical hypoglycemia and controls) participating in optional Visit 2. Magnitude of hypoglycemia will be correlated with metabolite levels during meal testing.
Measured: March 2025
Relationship between hormonal responses and magnitude of hypoglycemia as determined by CGM.
This is for a subset of participants (non-surgical hypoglycemia and controls) participating in optional Visit 2. Magnitude of hypoglycemia will be correlated with counterregulatory hormone levels during meal testing.
Measured: March 2025
Relationship between metabolic responses and microbiome.
This is for a subset of participants (non-surgical hypoglycemia and controls) participating in optional Visit 2. Metagenomic data will be correlated with metabolic responses during meal testing.
Measured: March 2025
Relationship between hormonal responses and microbiome.
This is for a subset of participants (non-surgical hypoglycemia and controls) participating in optional Visit 2. Metagenomic data will be correlated with counterregulatory hormone responses during meal testing.
Measured: March 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start11 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Elizabeth Patti, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428723
- Sponsor's protocol ID
- 00000095
- Status last verified
- Feb 2026
- First submitted
- 27 May 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data may be shared with other researchers with permission of local institutional review boards.
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
- Mechanisms of Hypoglycemia in Patients Without Diabetes
- ClinicalTrials.gov ID
- NCT04428723
- Acronym / sponsor ID
- 00000095
- Conditions
- Hypoglycemia
- Keywords
- Microbiome, DNA, Hormones, Genetics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2020 (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.
The goal of this study is to identify physiologic and molecular mechanisms that underlie hypoglycemia in the absence of diabetes (or medications that can cause hypoglycemia) and to investigate potential genetic and microbiome differences which contribute to hypoglycemia. We will test the hypothesis that hypoglycemia in the absence of diabetes is linked to genetic variation or the microbiome, and identify whether additional medical history or diagnoses are enriched in the population of patients with hypoglycemia.
Detailed description
Although there are several conditions which have been identified that cause, or contribute to hypoglycemia, diagnosis can be challenging, as the physiologic, and molecular mechanisms are incompletely understood. Additionally, treatment options are relatively limited, and often incompletely effective and/or not well tolerated. Investigating the causative factors and mechanisms of hypoglycemia is important therefore in improving our understanding in order to develop new and more effective approaches to treatment.
The current study aims to:
- more fully characterize clinical history and demographics in patients with diverse forms of hypoglycemia by creating and analyzing a patient database;
- for a subset of patients, characterize metabolic and hormonal responses to a standard meal;
- analyze DNA variants in individuals with hypoglycemia;
- analyze differences in the intestinal microbiome in individuals with hypoglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoglycemia, no upper gastrointestinal (GI) surgery | – | Other: Entry of demographic and medical history data into a deidentified database, Genetic: Blood sample for DNA analysis, Diagnostic Test: Stool sample for microbiome analysis, Diagnostic Test: Mixed meal tolerance test, Diagnostic Test: Continuous glucose monitoring, Diagnostic Test: activity monitorMales or females with hypoglycemia with neuroglycopenia, but no history of upper GI surgery, diabetes or prediabetes |
| Hypoglycemia, with history of upper GI surgery | – | Other: Entry of demographic and medical history data into a deidentified database, Genetic: Blood sample for DNA analysis, Diagnostic Test: Stool sample for microbiome analysis, Diagnostic Test: Mixed meal tolerance test, Diagnostic Test: Continuous glucose monitoring, Diagnostic Test: activity monitorMales or females with hypoglycemia with neuroglycopenia, with history of upper GI surgery |
| Controls, without hypoglycemia or upper GI surgery | – | Other: Entry of demographic and medical history data into a deidentified database, Genetic: Blood sample for DNA analysis, Diagnostic Test: Stool sample for microbiome analysis, Diagnostic Test: Mixed meal tolerance test, Diagnostic Test: Continuous glucose monitoring, Diagnostic Test: activity monitorMales or females with no history of upper gastrointestinal surgery, hypoglycemia, or diabetes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups: (1) patients with hypoglycemia, but without a history of bariatric or other gastrointestinal surgery, recruited from the Joslin Hypoglycemia Clinic, (2) patients with hypoglycemia and history of upper gastrointestinal surgery, recruited from the Joslin Hypoglycemia Clinic,(3) controls without hypoglycemia or surgery, recruited by local advertisement or from family members of patients with hypoglycemia. We plan to enroll patients with hypoglycemia continuously over the next 5 years.
Key inclusion criteria (5 listed)
- For hypoglycemia group without a history of bariatric surgery: Males or females diagnosed with hypoglycemia with prior episodes of neuroglycopenia.
- For hypoglycemia group with history of upper gastrointestinal surgery: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia.
- For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes.
- Age 18-70 years of age, inclusive, at screening.
- 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
Key exclusion criteria (22 listed)
- Active treatment with any diabetes medications except for acarbose;
- Known insulinoma, gastrinoma, or other neuroendocrine tumor;
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- 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;
- Congestive heart failure, New York Hear Association (NYHA) class II, III or IV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entry of demographic and medical history data into a deidentified databaseEntry into repository for analysis. | Other | Controls, without hypoglycemia or upper GI surgery, Hypoglycemia, no upper gastrointestinal (GI) surgery, Hypoglycemia, with history of upper GI surgery |
| Blood sample for DNA analysisTargeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls. | Genetic | Controls, without hypoglycemia or upper GI surgery, Hypoglycemia, no upper gastrointestinal (GI) surgery, Hypoglycemia, with history of upper GI surgery |
| Stool sample for microbiome analysisParticipants 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. | Diagnostic test | Controls, without hypoglycemia or upper GI surgery, Hypoglycemia, no upper gastrointestinal (GI) surgery, Hypoglycemia, with history of upper GI surgery |
| Mixed meal tolerance testAlso: Meal TestingFor 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. | Diagnostic test | Controls, without hypoglycemia or upper GI surgery, Hypoglycemia, no upper gastrointestinal (GI) surgery, Hypoglycemia, with history of upper GI surgery |
| Continuous glucose monitoringA 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. | Diagnostic test | Controls, without hypoglycemia or upper GI surgery, Hypoglycemia, no upper gastrointestinal (GI) surgery, Hypoglycemia, with history of upper GI surgery |
| activity monitorThe activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear. | Diagnostic test | Controls, without hypoglycemia or upper GI surgery, Hypoglycemia, no upper gastrointestinal (GI) surgery, Hypoglycemia, with history of upper GI surgery |
Primary outcome
Entry of medical history data into a deidentified database.
Time frame: March 2020 through March 2025
Medical history data will be entered into RedCap for analysis.
Entry of physical exam data into a deidentified database.
Time frame: March 2020 through March 2025
Pertinent physical exam data will be entered into RedCap for analysis.
Entry of laboratory data into a deidentified database.
Time frame: March 2020 through March 2025
Laboratory data will be entered into RedCap for analysis.
Entry of demographic data into a deidentified database.
Time frame: March 2020 through March 2025
Demographic data will be entered into RedCap for analysis.
Analysis of participant demographics and medical history, comparing the 3 study groups.
Time frame: March 2025
Demographic and medical history data will be summarized in RedCap and compared between groups using ANOVA or chi-square testing, depending on the variable analyzed.
Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing patients with hypoglycemia (both surgical and non-surgical) and healthy controls.
Time frame: March 2025
Sequence variants identified during targeted resequencing will be summarized and prevalence will be compared between groups and with population databases. Depending on results of targeted resequencing, additional expanded genotyping may be performed.
Analysis of microbiome, comparing study groups.
Time frame: March 2025
Microbiome will be characterized by sequencing to obtain metagenomic data and pathway analysis; all data will be adjusted for multiple comparisons.
Analysis of glucose patterns during masked continuous glucose monitoring (CGM), including time in range, time in hypoglycemia, time in hyperglycemia, comparing the study groups.
Time frame: March 2025
For a subset of participants who consent to participate in optional Visit 2, CGM data will be analyzed to assess mean, median, peak, and nadir sensor glucose values, glycemic variability (GV), severity and length of hypoglycemia (% time glucose <70, <60, <54 mg/dL), and number and duration of severe hypoglycemia (sensor glucose <54, duration >15 minutes) will be quantified. Metrics will be assessed over 24 hours and during daytime (6 AM to midnight) and nighttime (midnight to 6 AM) independently.
Analysis of metabolic responses during mixed meal testing.
Time frame: March 2025
For a subset of participants who consent to participate in optional Visit 2, magnitude of hypoglycemia will be correlated with metabolite levels during meal testing. Metabolites will be measured at set time points after the start of the mixed meal. Linear mixed effects modeling will be utilized to identify group- and time-dependent differences in metabolic responses. Data will be checked to ensure variables conform to assumptions of the analysis. Sensitivity analysis will determine whether missing data are randomly associated with clinical or experimental phenotypes, and assess the impact of missing data on conclusions. The relationship between clinical and metabolic variables will be analyzed using Pearson correlation, and adjusted for multiple comparisons using Benjamini-Hochberg testing.
Analysis of hormonal responses during mixed meal testing.
Time frame: March 2025
For a subset of participants who consent to participate in optional Visit 2, magnitude of hypoglycemia will be correlated with hormone levels during meal testing. Counterregulatory hormones will be measured at set time points after the start of the mixed meal. Linear mixed effects modeling will be utilized to identify group- and time-dependent differences in counterregulatory hormone responses. Data will be checked to ensure variables conform to assumptions of the analysis. Sensitivity analysis will determine whether missing data are randomly associated with clinical or experimental phenotypes, and assess the impact of missing data on conclusions. The relationship between clinical and hormonal variables will be analyzed using Pearson correlation, and adjusted for multiple comparisons using Benjamini-Hochberg testing.
4 secondary outcomes
Relationship between metabolic responses and magnitude of hypoglycemia as determined by CGM.
Time frame: March 2025
Relationship between hormonal responses and magnitude of hypoglycemia as determined by CGM.
Time frame: March 2025
Relationship between metabolic responses and microbiome.
Time frame: March 2025
Relationship between hormonal responses and microbiome.
Time frame: March 2025
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.
- recruitment website with contact informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified participant data may be shared with other researchers with permission of local institutional review boards.
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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 Elizabeth 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 5 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?
Entry of medical history data into a deidentified database. (time frame: March 2020 through March 2025). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.