Investigating how sympathetic blockade affects glucose production in obese hypertensive individuals
Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.
This study is testing if a new treatment can help people who are obese and have high blood pressure improve their blood sugar levels.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05312892 on ClinicalTrials.gov |
What this trial studies
This clinical trial examines the effects of sympathetic blockade on endogenous glucose production in obese hypertensive subjects through a randomized, crossover design. Participants will receive either a placebo, amlodipine, or moxonidine over a two-week period, with the treatment order determined by randomization. The study aims to assess whether these interventions can improve glucose metabolism in this population. Data analysis will be conducted by an investigator who is blinded to the treatment assignments to ensure objectivity.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 18 to 65 with obesity (BMI ≥ 30 kg/m2) and hypertension.
Not a fit: Patients with type I diabetes, significant cardiovascular disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for obesity and hypertension, potentially enhancing glucose metabolism in affected patients.
How similar studies have performed: Other studies have explored sympathetic blockade in relation to obesity and hypertension, but this specific crossover design may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females of all races between 18 and 65 years of age * Hypertension defined by two or more properly measured seated blood pressure readings \>130/85 mmHg or currently on antihypertensive medication. * Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m2. * Able and willing to provide informed consent. Exclusion Criteria: * Pregnancy or breast feeding * Current smokers or history of heavy smoking (\>2 packs/day) * History of alcohol or drug abuse * Previous allergic reaction to study medications * Type I diabetes. * Cardiovascular disease other than hypertension 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, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy * History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack * History or presence of immunological or hematological disorders * Impaired renal function * Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) * Treatment with any investigational drug in the 1 month preceding the study * Inability to give, or withdraw, informed consent * Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access)
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.