Monogenic DiabetesPhase 1NCT01795144
Incretin Regulation of Insulin Secretion in Monogenic Diabetes
A Phase 1 study testing GLP-1 and Exendin 9-39 in people with Monogenic Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Monogenic Diabetes
- What is being tested?
- GLP-1 and Exendin 9-39
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of monogenic diabetes
- Previously participated in US Neonatal Diabetes Registry (IRB 15617B) or Genetics of diabetes mellitus (IRB 6858)
- Age: 18 years +
- Good general health
- Stable weight for 6 months
- Age: 18 years +
Who cannot join
- Pregnancy
- Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension
- Healthy Controls:
- Pregnancy
- Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.
Read the detailed description
Monogenic diabetes patients and healthy matched controls will be admitted to the University of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on separate days:
- Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points
- Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points
- OGTT during GLP-1 infusion
- IGI during Exendin-9 infusion
- Conditions
- Monogenic Diabetes
- Being tested
- GLP-1, Exendin 9-39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called Glucagon-like peptide-1 (GLP-1)
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
Exendin 9-39Drug
Also called Glucagon-Like Peptide 1 (GLP-1) receptor antagonist
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Active comparator | Healthy controls will be matched (age, gender, BMI) to monogenic diabetes subjects. Healthy controls will participate in the following:
* OGTT
* IGI
* IGI with GLP-1 infusion
* OGTT with Exendin 9-39 infusion Receives: Drug: GLP-1; Drug: Exendin 9-39 |
| Monogenic diabetes | Experimental | Monogenic diabetes subjects will be matched (age, gender, BMI) to healthy controls. Monogenic diabetes subjects will participate in the following:
* OGTT
* IGI
* IGI with GLP-1 infusion
* OGTT with Exendin 9-39 infusion Receives: Drug: GLP-1; Drug: Exendin 9-39 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretin Effect
Directly calculated from the difference between oral and IV stimulated insulin secretion
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monogenic DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siri Atma W Greeley, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795144
- Sponsor's protocol ID
- 12-1517
- Status last verified
- Apr 2017
- First submitted
- 15 Feb 2013
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We do not plan to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incretin Regulation of Insulin Secretion in Monogenic Diabetes
- ClinicalTrials.gov ID
- NCT01795144
- Acronym / sponsor ID
- 12-1517
- Conditions
- Monogenic Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Feb 2013 (estimated)
- 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 purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.
Detailed description
Monogenic diabetes patients and healthy matched controls will be admitted to the University of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on separate days:
- Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points
- Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points
- OGTT during GLP-1 infusion
- IGI during Exendin-9 infusion
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Active comparator | Drug: GLP-1, Drug: Exendin 9-39Healthy controls will be matched (age, gender, BMI) to monogenic diabetes subjects. Healthy controls will participate in the following: * OGTT * IGI * IGI with GLP-1 infusion * OGTT with Exendin 9-39 infusion |
| Monogenic diabetes | Experimental | Drug: GLP-1, Drug: Exendin 9-39Monogenic diabetes subjects will be matched (age, gender, BMI) to healthy controls. Monogenic diabetes subjects will participate in the following: * OGTT * IGI * IGI with GLP-1 infusion * OGTT with Exendin 9-39 infusion |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of monogenic diabetes
- Previously participated in US Neonatal Diabetes Registry (IRB 15617B) or Genetics of diabetes mellitus (IRB 6858)
- Age: 18 years +
- Good general health
- Stable weight for 6 months
Key exclusion criteria (5 listed)
- Pregnancy
- Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension
- Pregnancy
- Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension
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 |
|---|---|---|
| GLP-1Also: Glucagon-like peptide-1 (GLP-1)OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion | Drug | Healthy controls, Monogenic diabetes |
| Exendin 9-39Also: Glucagon-Like Peptide 1 (GLP-1) receptor antagonistOGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion | Drug | Healthy controls, Monogenic diabetes |
Primary outcome
Incretin Effect
Time frame: Baseline
Directly calculated from the difference between oral and IV stimulated insulin secretion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: No. We do not plan to share data with other researchers.
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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.
Siri Atma W Greeley, MD, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLP-1 and Exendin 9-39 in people with Monogenic Diabetes, run by University of Chicago 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 10 Apr 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incretin Effect (time frame: Baseline). 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 10 Apr 2017.