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Alpha-2 Adrenergic Agonist

Anti-inflammatory Drugs for Obesity (MAPLE Trial)

Phase 1
Recruiting
Led By Seth W. W Holwerda, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female, age 18-79
Obese: BMI > 30 m/kg2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week
Awards & highlights

MAPLE Trial Summary

This trial will test if 4 weeks of sympathetic nerve activity inhibition can reduce circulating blood concentrations and expression of inflammatory markers.

Who is the study for?
This trial is for adults aged 18-79 with obesity (BMI >30), high blood pressure (>130/80 mmHg), and insulin resistance, but not diabetes. Participants should have a waist circumference over 102 cm for men or 88 cm for women, and be willing to visit the research lab. Those on hypertension meds, using clonidine or beta-blockers, with a history of heart disease or neurological disorders, smokers, or in other studies cannot join.Check my eligibility
What is being tested?
The study tests if inhibiting sympathetic nerve activity (SNA) with oral clonidine reduces inflammation markers compared to a diuretic (hydrochlorothiazide) or placebo. It's a prospective study where participants are randomly assigned to one of these three groups without knowing which one they're getting.See study design
What are the potential side effects?
Clonidine may cause dry mouth, drowsiness, headache and could lower blood pressure too much. Hydrochlorothiazide might lead to increased urination, dehydration, electrolyte imbalance and light sensitivity.

MAPLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old.
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My BMI is over 30.

MAPLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adipose Tissue Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment
Clonidine
Clonidine

MAPLE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Hydrochlorothiazide (HCTZ)Experimental Treatment1 Intervention
KU Investigational Pharmacy will provide the drug prescription bottle with 35-day supply of Hydrochlorothiazide to the research coordinator to give to the research participant. Planned use in this study Condition/disease indication(s): Hypertension Subject population: Hypertension Dose(s): 25 mg/day Administration: Oral Dosing regimen: 12.5 mg twice per day
Group II: ClonidineExperimental Treatment1 Intervention
KU Investigational Pharmacy will provide the drug prescription bottle with 35-day supply of clonidine to the research coordinator to give to the research participant. Planned use in this study Condition/disease indication(s): Vascular function and blood flow Subject population: Hypertension Dose(s): 0.1 mg (oral) Administration: Oral Dosing regimen: 0.1 mg twice daily by mouth
Group III: PlaceboPlacebo Group1 Intervention
KU Investigational Pharmacy will provide the drug prescription bottle with 35-day supply of placebo to the research coordinator to give to the research participant. The placebo is an inert substance with no intended medical value and is used as a negative control for comparison with the study drug. Participants will receive a Placebo Pill; has no active ingredients but is made to look like the study drug.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,210 Total Patients Enrolled
19 Trials studying Obesity
103,552 Patients Enrolled for Obesity
Seth W. W Holwerda, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04934228 — Phase 1
Obesity Research Study Groups: Placebo, Clonidine, Hydrochlorothiazide (HCTZ)
Obesity Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT04934228 — Phase 1
Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04934228 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Clonidine Pill?

"With limited clinical data available to support it, the safety of Clonidine Pill was rated as a 1 on our scale at Power. This is reflective of its Phase 1 trial status."

Answered by AI

Does this experimental research include elderly people as participants?

"For this clinical trial, only individuals aged between 18 and 79 may enroll. Those under the age of 18 have access to 252 studies while those older than 65 can choose from 932 alternatives."

Answered by AI

Are there still opportunities to participate in this experiment?

"According to clinicaltrials.gov, this experiment is still recruiting participants since it was first posted on July 1st 2021 and edited most recently June 15th 2022."

Answered by AI

How many participants is the research team recruiting for this investigation?

"Affirmative. The clinical trial is actively recruiting participants, as the information on clinicaltrials.gov indicates. This study was initially posted on July 1st 2021 and saw its last update on June 15th 2022; currently it seeks to enrol 60 patients from one site."

Answered by AI

To what symptoms is Clonidine Pill typically prescribed?

"Clinically, clonidine pill has been utilized to alleviate left ventricular hypertrophy. Additionally, it can be a beneficial tool in treating edema, attention deficit hyperactivity disorder (ADHD), and pheochromocytomas."

Answered by AI

What are the eligibility requirements to participate in this research project?

"This study is recruiting 60 individuals who suffer from obesity and fall within the specified age range. Qualifying applicants must possess a Body Mass Index greater than 30m/kg2, have elevated blood pressure (above 130/80), and display a waist circumference of more than 102 cm for men or 88 cm for women."

Answered by AI

Could you provide a list of research projects that have been conducted with Clonidine Pill?

"Currently, 29 clinical trials for Clonidine Pill are in progress. Out of those studies, 11 have reached phase 3 and 149 different sites are running investigations on this medication. Lexington Kentucky is the most prevalent location hosting these medical experiments."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Missouri
How old are they?
65+
18 - 65
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Length of study, length of visits? Financial compensation? What is time investment? How many visits? Duration of visits? Is the financial compensation?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Saw it on email.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Mitigating the Pro-inflammatory Phenotype of Obesity
Seth Holwerda PhD 2021. "Mitigating the Pro-inflammatory Phenotype of Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04934228.
~19 spots leftby Jul 2025
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