What side effects are associated with this type of intervention?

Common treatments for obesity include medications like metformin, topiramate, liraglutide, and semaglutide. Metformin is generally well-tolerated but can cause gastrointestinal issues such as diarrhea and nausea. Topiramate may lead to cognitive side effects, such as memory problems and difficulty concentrating, as well as paresthesia. Liraglutide and semaglutide, both GLP-1 receptor agonists, are associated with gastrointestinal side effects, including nausea, vomiting, and diarrhea. Clonidine, used for sympathetic nerve activity inhibition, can cause side effects such as dry mouth, drowsiness, and hypotension. These side effects should be discussed with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including those that target sympathetic nerve activity. Clonidine, an alpha-2 adrenergic agonist, is primarily used for hypertension but has been studied for its potential in reducing sympathetic nerve activity and inflammation. Other FDA-approved drugs for obesity include orlistat, which reduces fat absorption, and liraglutide, a GLP-1 receptor agonist that regulates appetite. Sibutramine, which also affected sympathetic nerve activity, was withdrawn from the market due to cardiovascular risks. These treatments highlight the diverse mechanisms through which obesity can be managed pharmacologically.

What other types of research exist?

Promising novel alternatives to Clonidine for obesity treatment in 2024 include GLP-1 receptor agonists (e.g., semaglutide), which have shown significant efficacy in weight loss and metabolic improvements. Additionally, metabolic surgery options like laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass continue to be effective for long-term weight management and metabolic health. These alternatives offer different mechanisms of action compared to Clonidine but are promising for comprehensive obesity management.

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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

Must not have

Currently taking hypertension medication

History of heart disease (e.g., myocardial infarction, stent, bypass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 week

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for high blood pressure.

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I have a history of heart disease.

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I am currently taking clonidine or beta-blockers.

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I have a history of neurological disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 week

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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 1. Condition/disease indication(s): Hypertension 2. Subject population: Hypertension 3. Dose(s): 25 mg/day 4. Administration: Oral 5. 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 1. Condition/disease indication(s): Vascular function and blood flow 2. Subject population: Hypertension 3. Dose(s): 0.1 mg (oral) 4. Administration: Oral 5. 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include lifestyle modifications, pharmacotherapy, and bariatric surgery. Lifestyle changes focus on diet and exercise to reduce caloric intake and increase energy expenditure. Pharmacotherapy involves medications like orlistat, which inhibits fat absorption, and liraglutide, which mimics GLP-1 to reduce appetite. Clonidine, which inhibits sympathetic nerve activity, reduces circulating inflammatory markers and may help mitigate the pro-inflammatory phenotype of obesity. Understanding these mechanisms is crucial for obesity patients as it helps tailor treatments to individual needs, improving efficacy and minimizing adverse effects.