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Anti-inflammatory
Colchicine for Obesity and Insulin Resistance
Phase 2
Recruiting
Led By Jack A Yanovski, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18y for adults; age 12y to <18y for adolescents
Obesity BMI >= 30 kg/m2 (adults) or BMI >= 95th percentile for age and sex per Centers for Disease Control Standards (adolescents)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 3 months
Awards & highlights
Study Summary
This trial is testing whether or not the anti-inflammatory drug colchicine can help improve metabolism in people who are overweight, have increased inflammation, and high insulin levels but have not yet developed high blood sugar.
Who is the study for?
This trial is for people aged 12 and older who are significantly overweight, with a BMI over 30 kg/m2 for adults or above the 95th percentile for children. They should have signs of inflammation (hsCRP >= 2.0 mg/L) and insulin resistance (HOMA-IR >= 2.6), but not diabetes (HbA1c <=7%). Women must use effective contraception if able to conceive.Check my eligibility
What is being tested?
Researchers are testing whether colchicine, an anti-inflammatory medication, can improve metabolism in obese individuals with high levels of inflammation and insulin without high blood sugar yet. Participants will take either colchicine or a placebo daily for up to four months, including check-ins and tests like OGTT.See study design
What are the potential side effects?
Colchicine may cause side effects such as digestive issues (nausea, diarrhea), blood disorders, muscle pain or weakness. Not everyone will experience these side effects; some might have none at all.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old, or I am an adolescent aged 12 to 17.
Select...
My BMI is 30 or higher as an adult, or above the 95th percentile for my age and sex if I'm an adolescent.
Select...
My weight is 450 lbs or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Homeostatic model assessment of insulin resistance (HOMA-IR)
Secondary outcome measures
Change in High-Sensitivity C-Reactive Protein
Change in Matsuda Index
Change in fasting serum glucose
+1 moreSide effects data
From 2021 Phase 4 trial • 280 Patients • NCT017099811%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Colchicine - AdultsExperimental Treatment1 Intervention
Adults given Colchicine 0.6 mg per day (1 capsule per day)
Group II: Colchicine - AdolescentsExperimental Treatment1 Intervention
Adolescents given Colchicine 0.6 mg per day (1 capsule per day)
Group III: Adults no obesity, insulin resistance, or inflammationActive Control1 Intervention
Adults without obesity, insulin resistance or inflammation
Group IV: Adults with obesity, but no insulin resistance/inflammationActive Control1 Intervention
Adults with obesity, but without insulin resistance or inflammation
Group V: Placebo - AdolescentsPlacebo Group1 Intervention
Adolescents given Placebo (1 capsule per day)
Group VI: Placebo - AdultsPlacebo Group1 Intervention
Adults given Placebo (1 capsule per day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
2020
Completed Phase 4
~12140
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,965 Previous Clinical Trials
2,672,297 Total Patients Enrolled
104 Trials studying Obesity
96,572 Patients Enrolled for Obesity
Jack A Yanovski, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
23 Previous Clinical Trials
6,768 Total Patients Enrolled
14 Trials studying Obesity
3,409 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have major health problems or serious conditions, as decided by the researchers.I am at least 18 years old, or I am an adolescent aged 12 to 17.You have had a serious condition called agranulocytosis, gout, or significant myositis in the past.I have had a condition where my lymphocytes multiply unusually.I have a history of cancer.My HbA1c is above 7.0% or I have Type 2 diabetes.My race, ethnicity, or gender does not exclude me from this trial.I am currently taking medication that strongly affects liver enzymes or drug transporters.I am not pregnant, planning a pregnancy, breastfeeding, or have irregular periods.I am in good health and meet the medication criteria for the study.I haven't had cancer in the last 5 years, except for skin cancer.I am in good health and generally don't take any medications.I regularly use medications like colchicine, diet pills, diabetes drugs, or anti-inflammatory drugs.My BMI is 30 or higher as an adult, or above the 95th percentile for my age and sex if I'm an adolescent.Your insulin resistance level, calculated using a formula with your fasting glucose and insulin levels, is higher than 2.6.You are allergic to colchicine.Criterion: You do not live in the United States.Your hsCRP level is higher than 2.0 mg/L.I am willing to participate in a study and can give consent.You currently have a substance abuse problem or a serious mental health condition.You currently use tobacco or products containing nicotine.My race, ethnicity, or gender does not exclude me from this trial.I am 18 or older with a BMI of 18 or more.My weight is 450 lbs or less.I have recently lost or gained more than 3% of my body weight.You weigh enough for your height.inclusion criteria:
People who will be randomized to colchicine or placebo must meet all of the following inclusion criteria: they must have gout, they must have a flare-up, and they must be willing to take medication.
Research Study Groups:
This trial has the following groups:- Group 1: Adults no obesity, insulin resistance, or inflammation
- Group 2: Adults with obesity, but no insulin resistance/inflammation
- Group 3: Colchicine - Adolescents
- Group 4: Colchicine - Adults
- Group 5: Placebo - Adolescents
- Group 6: Placebo - Adults
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved with this experimental program?
"Correct, the data presented on clinicaltrials.gov states that this medical trial is still recruiting patients. It was initially posted on November 8th 2021 and most recently updated on September 14th 2022. The researchers hope to recruit 500 participants from a single site."
Answered by AI
What other research initiatives have been undertaken that involve Colchicine?
"Currently, 31 research trials on colchicine are in progress. Of those studies, 12 have reached the third and final stage of assessment. New york is the primary city for this type of study; however, there are 98 other sites conducting experiments as well."
Answered by AI
What ailments does Colchicine typically treat?
"Colchicine is mostly prescribed to ease the suffering of those contending with gout flares, but it can also help individuals struggling with familial mediterranean fever, postcommissurotomy syndrome and behcet's syndrome."
Answered by AI
Is there still an opportunity for participation in this clinical trial?
"According to clinicaltrials.gov, this health research initiative is presently seeking volunteers and has been since November 8th 2021. The most recent changes were made on September 14th 2022."
Answered by AI
Are there any known adverse effects associated with Colchicine intake?
"The clinical data around Colchicine's safety is still developing, so it has been assigned a score of 2. Although the medication shows promise in regards to safety, there are no studies at this point that assess its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
New York
How old are they?
18 - 65
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 48 hours
Average response time
- < 2 Days
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