Phase 2 Completed N=23 Randomized Double-blind Treatment

Racial Differences in Vagal Control of Glucose Homeostasis

Obesity

Source: ClinicalTrials.gov NCT02365285 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcomePrimary: Change in Oxidative Stress: Baseline to 2 Hours — -0.003; -0.006; 0.01; -0.006 pg /ml

Summary

The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.

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	—

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

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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. Informational only — not medical advice.