Post-Bariatric HypoglycemiaNCT04615546
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
A study testing Use of Continuous Glucose Monitor (CGM) and Use of "Cardea Solo" monitoring in people with Post-Bariatric Hypoglycemia, run by Stanford University at 1 site in United States.
Trial summary
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Bariatric Hypoglycemia
- What is being tested?
- Use of Continuous Glucose Monitor (CGM) and Use of "Cardea Solo" monitoring
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2020to Jun 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients 18-70 years of age
- Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
- Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)
Who cannot join
- Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
- Participation in any clinical investigation within 4 weeks prior to dosing
- History of or current insulinoma
- Active infection or significant acute illness within 2 weeks prior to dosing
- Female patients who are pregnant or lactating
- Women of childbearing potential and not utilizing effective contraceptive methods
- Inadequate end organ function as defined by: Serum creatinine >2.0 mg/dL, alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2 x Upper Normal Limit
- Allergy to test meal or medications used in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305-5103
Colleen Craig, MD, 650-724-2474, cmcraig@stanford.edu
About this study
Official title: Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.
- Conditions
- Post-Bariatric Hypoglycemia
- Being tested
- Use of Continuous Glucose Monitor (CGM), Use of "Cardea Solo" monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Continuous Glucose Monitor (CGM)Behavioural
Participants will wear CGM
Use of "Cardea Solo" monitoringOther
Participants will wear a "Cardea Solo" patch during blinded CGM use
| Study group | Role | What they receive |
|---|---|---|
| Remote Phase: Post-Bariatric Hypoglycemia Patients | Experimental | Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days. Receives: Behavioral: Use of Continuous Glucose Monitor (CGM); Other: Use of "Cardea Solo" monitoring |
| In-Clinic Phase: Post-Bariatric Hypoglycemia Patients | No intervention | Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants. |
| In-Clinic Phase: Surgical Controls | No intervention | Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. |
| In-Clinic Phase: Nonsurgical Controls | No intervention | Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. |
| In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube | No intervention | Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state plasma glucose (SSPG) as a measure of insulin sensitivity
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is a one day in-person appointment lasting approximately 6 hours.
Measured: Baseline 4-hour SSPG
Rate of gastric emptying
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is an in-person appointment lasting approximately 5 hours.
Measured: Baseline 4-hour scintigraphy procedure
Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. The blood collected from the SSPG will be stored and analyzed for the concentration of GLP-1 at multiple timepoints.
Measured: Baseline 4-hour graded-glucose infusion
Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
This endpoint applies to Remote Phase participants
Measured: 40 days
Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
This endpoint applies to Remote Phase participants
Measured: 40 days
Rate of arrhythmia during hypoglycemia
This endpoint applies to Remote Phase participants
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start6 May 2020
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Bariatric HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Tracey McLaughlin, Stanford University
- Investigators
- Tracey McLaughlin, MD, Principal investigator, Stanford UniversityColleen Craig, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615546
- Sponsor's protocol ID
- 52254
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2020
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
- ClinicalTrials.gov ID
- NCT04615546
- Acronym / sponsor ID
- 52254
- Conditions
- Post-Bariatric Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 6 May 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Nov 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.
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Remote Phase: Post-Bariatric Hypoglycemia Patients | Experimental | Behavioral: Use of Continuous Glucose Monitor (CGM), Other: Use of "Cardea Solo" monitoringParticipants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days. |
| In-Clinic Phase: Post-Bariatric Hypoglycemia Patients | No intervention | –Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants. |
| In-Clinic Phase: Surgical Controls | No intervention | –Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. |
| In-Clinic Phase: Nonsurgical Controls | No intervention | –Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. |
| In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube | No intervention | –Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients 18-70 years of age
- Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
- Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)
Key exclusion criteria (8 listed)
- Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
- Participation in any clinical investigation within 4 weeks prior to dosing
- History of or current insulinoma
- Active infection or significant acute illness within 2 weeks prior to dosing
- Female patients who are pregnant or lactating
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 |
|---|---|---|
| Use of Continuous Glucose Monitor (CGM)Participants will wear CGM | Behavioural | Remote Phase: Post-Bariatric Hypoglycemia Patients |
| Use of "Cardea Solo" monitoringParticipants will wear a "Cardea Solo" patch during blinded CGM use | Other | Remote Phase: Post-Bariatric Hypoglycemia Patients |
Primary outcome
Steady state plasma glucose (SSPG) as a measure of insulin sensitivity
Time frame: Baseline 4-hour SSPG
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is a one day in-person appointment lasting approximately 6 hours.
Rate of gastric emptying
Time frame: Baseline 4-hour scintigraphy procedure
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is an in-person appointment lasting approximately 5 hours.
Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate
Time frame: Baseline 4-hour graded-glucose infusion
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. The blood collected from the SSPG will be stored and analyzed for the concentration of GLP-1 at multiple timepoints.
Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
Time frame: 40 days
This endpoint applies to Remote Phase participants
Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
Time frame: 40 days
This endpoint applies to Remote Phase participants
Rate of arrhythmia during hypoglycemia
Time frame: 10 days
This endpoint applies to Remote Phase participants
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 4 Dec 2024.
- 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.
Tracey McLaughlin, MD principal investigator
Stanford University
Colleen Craig, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Continuous Glucose Monitor (CGM) and Use of "Cardea Solo" monitoring in people with Post-Bariatric Hypoglycemia, run by Stanford University 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 8 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady state plasma glucose (SSPG) as a measure of insulin sensitivity (time frame: Baseline 4-hour SSPG). The study lists 6 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 4 Dec 2024.