Anti-inflammatory Drugs for Obesity
(MAPLE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if taking clonidine for a short period can reduce inflammation in patients with high nerve activity. Clonidine calms these nerves, potentially lowering blood pressure and inflammation.
Will I have to stop taking my current medications?
The trial requires that you are not currently taking hypertension medication or clonidine. If you are on these medications, you would need to stop taking them to participate.
Is Clonidine safe for use in humans?
How does the drug Clonidine differ from other obesity treatments?
Clonidine is unique in obesity treatment because it primarily acts as an anti-inflammatory drug, which is not a common mechanism among traditional obesity medications that typically focus on appetite suppression or nutrient absorption. This novel approach may offer a different pathway for managing obesity, especially for patients where inflammation plays a significant role in their condition.678910
What data supports the effectiveness of the drug Clonidine for obesity?
Clonidine is known to be effective in reducing blood pressure in patients with mild to moderate hypertension, and it is also used for detoxification in opiate addiction. However, there is no direct evidence from the provided research articles supporting its effectiveness for treating obesity.1112131415
Who Is on the Research Team?
Seth W. W Holwerda, PhD
Principal Investigator
University of Kansas Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 weeks of SNA blockade with oral clonidine, hydrochlorothiazide, or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clonidine
- Hydrochlorothiazide 12.5Mg Tab
- Placebo
Clonidine is already approved in United States, European Union for the following indications:
- Hypertension
- ADHD
- Severe cancer pain
- Withdrawal symptoms from various substances
- Diagnosis of pheochromocytoma
- Prevention of migraines
- Hypertension
- ADHD
- Severe cancer pain
- Withdrawal symptoms from various substances
- Diagnosis of pheochromocytoma
- Prevention of migraines
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor