Phase 2
N=23
Racial Differences in Vagal Control of Glucose Homeostasis
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02365285 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in Oxidative Stress: Baseline to 2 Hours — -0.003; -0.006; 0.01; -0.006 pg /ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Galantamine (Drug); Placebo Oral Capsule (Drug); Intralipid (Drug); Heparin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oxidative Stress: Baseline to 2 Hours |
-0.003; -0.006; 0.01; -0.006 | — |
| PRIMARY Change in Oxidative Stress: Baseline to 4 Hours |
0; -0.008; 0.003; -0.008 | — |
Summary
The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 atrioventricular (AV) block)
- Significant weight change >5% in the past 3 months
- Impaired hepatic function (AST and/or Alanine transaminase (ALT) > one and one half times (1.5X) upper limit of normal range)
- Impaired renal function (eGFR <60ml/min)
- Users of strong inhibitors of Cytochrome P450 3A4 (CYP3A4) or cytochrome P450, family 2, subfamily D, polypeptide 6 (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
Data sourced from ClinicalTrials.gov (NCT02365285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.