Insulin SensitivityPhase 1RDVCGHNCT03014323
Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study
A Phase 1 study testing Galantamine in people with Insulin Sensitivity and Oxidative Stress, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Oxidative Stress
- What is being tested?
- Galantamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- African American or white (race will be self-defined, but only subjects who report both parents of the same race will be included)
- 18-60 years old
- BMI 30-45 Kg/m2
- Not pregnant or breastfeeding
Who cannot join
- Pregnant or breastfeeding
- Diabetes diagnosis (defined by the American Diabetes Association (ADA) criteria)38
- Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy.
- Arrhythmia (first-, second-, and third-degree AV block)
- Significant weight change >5% in the past 3 months
- Impaired hepatic function (AST and/or ALT >1.5X upper limit of normal range)
Show all 15Show fewer
- Impaired renal function (eGFR <60ml/min)
- Users of strong inhibitors of CYP3A4 or CYP2D6
- Users of other acetylcholinesterase inhibitors such as pyridostigmine or bethanechol
- History of alcohol or drug abuse
- Mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- Steroid use within 6 weeks prior to study entry
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- Discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women.
Read the detailed description
Investigators will test the hypothesis that chronic restoration of parasympathetic nervous system (PNS) activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American women (AAW) compared to white women (WW). A cross-over study will be performed in matched cohorts of AAW and white women subjected to chronic central acetylcholinesterase inhibition with galantamine versus placebo, given orally over a 4-week period. Insulin sensitivity will be measured using the gold standard hyperinsulinemic-euglycemic clamp. Adipose tissue will be obtained through subcutaneous fat biopsies where F2-isoprostanes will be quantified.
- Conditions
- Insulin Sensitivity, Oxidative Stress
- Being tested
- Galantamine, Placebo
- Keywords
- insulin sensitivity, African American, obese
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
Also called Razadyne
Galantamine 4 mg twice a day for 4 weeks
PlaceboDrug
Also called Razadyne
Placebo 1 capsule twice a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Galantamine then Placebo, WW | Experimental | 4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in white women (WW) Receives: Drug: Galantamine; Drug: Placebo |
| Placebo then Galantamine, WW | Placebo comparator | Placebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks in white women (WW) Receives: Drug: Galantamine; Drug: Placebo |
| Galantamine then Placebo, AAW | Experimental | 4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in African American Women (AAW) Receives: Drug: Galantamine; Drug: Placebo |
| Placebo then Galantamine, AAW | Placebo comparator | Placebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks African American Women (AAW) Receives: Drug: Galantamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: No fundings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cyndya Shibao, Vanderbilt University Medical Center
- Investigators
- Cyndya A Shibao, MD, Principal investigator, Vanderbilt University Medical Center, Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014323
- Sponsor's protocol ID
- 141552-specific aim 2
- Acronym
- RDVCGH
- Status last verified
- Aug 2018
- First submitted
- 3 Jan 2017
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study
- ClinicalTrials.gov ID
- NCT03014323
- Acronym / sponsor ID
- RDVCGH / 141552-specific aim 2
- Conditions
- Insulin Sensitivity, Oxidative Stress
- Keywords
- insulin sensitivity, African American, obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No fundings
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Jan 2017 (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.
Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women.
Detailed description
Investigators will test the hypothesis that chronic restoration of parasympathetic nervous system (PNS) activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American women (AAW) compared to white women (WW). A cross-over study will be performed in matched cohorts of AAW and white women subjected to chronic central acetylcholinesterase inhibition with galantamine versus placebo, given orally over a 4-week period. Insulin sensitivity will be measured using the gold standard hyperinsulinemic-euglycemic clamp. Adipose tissue will be obtained through subcutaneous fat biopsies where F2-isoprostanes will be quantified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Galantamine then Placebo, WW | Experimental | Drug: Galantamine, Drug: Placebo4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in white women (WW) |
| Placebo then Galantamine, WW | Placebo comparator | Drug: Galantamine, Drug: PlaceboPlacebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks in white women (WW) |
| Galantamine then Placebo, AAW | Experimental | Drug: Galantamine, Drug: Placebo4 mg (1 capsule) galantamine twice a day for 4 weeks then placebo (1 capsule) twice a day for 4 weeks in African American Women (AAW) |
| Placebo then Galantamine, AAW | Placebo comparator | Drug: Galantamine, Drug: PlaceboPlacebo (1 capsule) twice a day for 4 weeks then 4 mg (1 capsule) galantamine twice a day for 4 weeks African American Women (AAW) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- African American or white (race will be self-defined, but only subjects who report both parents of the same race will be included)
- 18-60 years old
- BMI 30-45 Kg/m2
- Not pregnant or breastfeeding
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding
- Diabetes diagnosis (defined by the American Diabetes Association (ADA) criteria)38
- Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy.
- Arrhythmia (first-, second-, and third-degree AV block)
- Significant weight change >5% in the past 3 months
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 |
|---|---|---|
| GalantamineAlso: RazadyneGalantamine 4 mg twice a day for 4 weeks | Drug | Galantamine then Placebo, AAW, Galantamine then Placebo, WW, Placebo then Galantamine, AAW, Placebo then Galantamine, WW |
| PlaceboAlso: RazadynePlacebo 1 capsule twice a day for 4 weeks | Drug | Galantamine then Placebo, AAW, Galantamine then Placebo, WW, Placebo then Galantamine, AAW, Placebo then Galantamine, WW |
Primary outcome
insulin sensitivity
Time frame: 4 weeks
insulin sensitivity will be measured with hyperinsulinemic euglycemic clamps
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No. No sharing
Related trials for Insulin Sensitivity
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre 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.
Cyndya A Shibao, MD principal investigator
Vanderbilt University Medical Center, Clinical Pharmacology
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 Galantamine in people with Insulin Sensitivity and Oxidative Stress, run by Vanderbilt University Medical 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 15 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: withdrawn, as of the sponsor's last update on 13 Aug 2018. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
insulin sensitivity (time frame: 4 weeks). 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 13 Aug 2018.