Diabetes MellitusPhase 1AchENCT03063515
AchE Inhibitor and Insulin
A Phase 1 study testing Pyridostigmine in people with Diabetes Mellitus, run by University of Miami at 1 site in United States.
Trial summary
The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pyridostigmine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 14 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
Who cannot join
- BMI >30 Kg/m2
- fasting glucose >100
- Glycohemoglobin (Hemoglobin A1C) 5.7% or more
- History of asthma
- Use of medications that may interfere with glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings
The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. The test will be carried out twice, once without and once with the administration of a single dose of Pyridostigmine on two separate days. The investigator hypothesizes that inhibiting AChE will potentiate insulin secretion.
- Conditions
- Diabetes Mellitus
- Being tested
- Pyridostigmine
- Keywords
- Insulin secretion
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyridostigmineDrug
Also called Mestinon
single oral dose of 60 mg pyridostigmine tablet
| Study group | Role | What they receive |
|---|---|---|
| IVGTT without pyridostigmine | No intervention | An intravenous glucose tolerance test (IVGTT) will be performed without any medication for baseline comparison. |
| IVGTT with pyridostigmine | Active comparator | An IVGTT will be performed 2 hours after taking one single dose of pyridostigmine 60 mg Receives: Drug: Pyridostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First phase insulin response to IV glucose infusion
Insulin positive incremental area under the curve and the sum of plasma insulin values at 1 minute and 3 minutes after IV glucose infusion
Measured: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
Secondary outcomes (1)
Glucose excursion after IV glucose infusion
Glucose positive incremental area under the curve
Measured: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start19 Apr 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Maria del Pilar Solano, University of Miami
- Investigators
- Maria del Pilar Solano, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063515
- Sponsor's protocol ID
- 20161065
- Acronym
- AchE
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings
- ClinicalTrials.gov ID
- NCT03063515
- Acronym / sponsor ID
- AchE / 20161065
- Conditions
- Diabetes Mellitus
- Keywords
- Insulin secretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 24 Feb 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.
The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. The test will be carried out twice, once without and once with the administration of a single dose of Pyridostigmine on two separate days. The investigator hypothesizes that inhibiting AChE will potentiate insulin secretion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVGTT without pyridostigmine | No intervention | –An intravenous glucose tolerance test (IVGTT) will be performed without any medication for baseline comparison. |
| IVGTT with pyridostigmine | Active comparator | Drug: PyridostigmineAn IVGTT will be performed 2 hours after taking one single dose of pyridostigmine 60 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years and older
Key exclusion criteria (5 listed)
- BMI >30 Kg/m2
- fasting glucose >100
- Glycohemoglobin (Hemoglobin A1C) 5.7% or more
- History of asthma
- Use of medications that may interfere with glucose metabolism
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 |
|---|---|---|
| PyridostigmineAlso: Mestinonsingle oral dose of 60 mg pyridostigmine tablet | Drug | IVGTT with pyridostigmine |
Primary outcome
First phase insulin response to IV glucose infusion
Time frame: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
Insulin positive incremental area under the curve and the sum of plasma insulin values at 1 minute and 3 minutes after IV glucose infusion
1 secondary outcome
Glucose excursion after IV glucose infusion
Time frame: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
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 27 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Maria del Pilar Solano, MD principal investigator
University of Miami
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 Pyridostigmine in people with Diabetes Mellitus, run by University of Miami 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 1 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 27 Feb 2019. 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?
First phase insulin response to IV glucose infusion (time frame: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes). 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 27 Feb 2019.