Trial Outcomes & Findings for Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity (NCT NCT04329806)

NCT ID: NCT04329806

Last Updated: 2025-09-05

Results Overview

Dose response curve to insulin (measure as glucose infusion rate, mg/kg/min)

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2025-09-05

Participant Flow

Participant milestones

Measure	Moxonidine Moxonidine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Moxonidine 0.2 MG: Moxonidine 0.2 MG twice daily	Amlodipine Amlodipine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Amlodipine 5 MG: Amlodipine 5 MG twice daily
Overall Study STARTED	5	5
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Moxonidine Moxonidine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Moxonidine 0.2 MG: Moxonidine 0.2 MG twice daily	Amlodipine Amlodipine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Amlodipine 5 MG: Amlodipine 5 MG twice daily
Overall Study Physician Decision	3	4

Baseline Characteristics

Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity

Baseline characteristics by cohort

Measure	Moxonidine n=5 Participants Moxonidine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Moxonidine 0.2 MG: Moxonidine 0.2 MG twice daily	Amlodipine n=5 Participants Amlodipine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Amlodipine 5 MG: Amlodipine 5 MG twice daily	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 5 • n=5 Participants	41 years STANDARD_DEVIATION 6 • n=7 Participants	42 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Dose response curve to insulin (measure as glucose infusion rate, mg/kg/min)

Outcome measures

Measure	Moxonidine n=4 Participants Moxonidine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Moxonidine 0.2 MG: Moxonidine 0.2 MG twice daily The main outcome is insulin sensitivity (measured as glucose infusion rate in mg/kg/min during the last 30 minutes of the clamp).	Amlodipine n=4 Participants Amlodipine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks Amlodipine 5 MG: Amlodipine 5 MG twice daily The main outcome is insulin sensitivity (measured as glucose infusion rate in mg/kg/min during the last 30 minutes of the clamp).
Insulin Sensitivity	4.3 mg/kg/min Standard Deviation 3.1	3.6 mg/kg/min Standard Deviation 3.3

Adverse Events

Moxonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amlodipine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alfredo Gamboa

Vanderbilt University Medical Center

Phone: 615 875 1003

Email: alfredo.gamboa@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place