500 Participants Needed
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) logo

Colchicine for Obesity and Insulin Resistance

Recruiting in Bethesda (>99 mi)
SM
JA
Overseen ByJack A Yanovski, M.D.
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether colchicine, a medication usually used for gout, can help improve metabolism in people with high body weight and inflammation. The study focuses on individuals aged 12 and older who have high insulin levels but not high blood sugar. Colchicine aims to reduce inflammation that contributes to insulin resistance and other health problems. Colchicine has been studied for its potential anti-diabetic properties, showing it can significantly reduce blood glucose levels.

Will I have to stop taking my current medications?

The trial requires that participants generally take no medications, except for certain allowed ones like contraceptives, antihypertensives, and statins. Other medications will be reviewed individually, and you may need to stop taking some medications at least 3 months before joining the study.

How is the drug colchicine unique for treating obesity and insulin resistance?

Colchicine is unique because it is traditionally used to treat gout and inflammation, and its use for obesity and insulin resistance is novel. Unlike standard treatments like metformin or rosiglitazone, colchicine's mechanism of action involves reducing inflammation, which may offer a different approach to managing insulin resistance.12345

Who Is on the Research Team?

JA

Jack A Yanovski, M.D.

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
I am at least 18 years old, or I am an adolescent aged 12 to 17.
My race, ethnicity, or gender does not exclude me from this trial.
See 10 more

Exclusion Criteria

You have major health problems or serious conditions, as decided by the researchers.
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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Participants undergo baseline assessments including an Oral Glucose Tolerance Test (OGTT) and receive a 12-week supply of the study drug or placebo

1 day
1 visit (in-person)

Treatment

Participants take the study drug or placebo daily for 12 weeks, with study visits at 6 weeks and 12 weeks

12 weeks
2 visits (in-person), 3 phone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat OGTT at the 12-week visit

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Colchicine
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Colchicine - AdultsExperimental Treatment1 Intervention
Group II: Colchicine - AdolescentsExperimental Treatment1 Intervention
Group III: Adults no obesity, insulin resistance, or inflammationActive Control1 Intervention
Group IV: Adults with obesity, but no insulin resistance/inflammationActive Control1 Intervention
Group V: Placebo - AdolescentsPlacebo Group1 Intervention
Group VI: Placebo - AdultsPlacebo Group1 Intervention

Colchicine is already approved in United States for the following indications:

🇺🇸
Approved in United States as Colcrys for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Lead Sponsor

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

In a 12-week pilot study involving 7 overweight or obese subjects with acanthosis nigricans, only rosiglitazone significantly reduced insulin levels, suggesting a potential metabolic benefit.
Both metformin and rosiglitazone were well-tolerated, but neither showed a significant effect on the severity of acanthosis nigricans lesions, indicating that longer treatment periods may be necessary to observe more substantial improvements.
Comparison of metformin versus rosiglitazone in patients with Acanthosis nigricans: a pilot study.Bellot-Rojas, P., Posadas-Sanchez, R., Caracas-Portilla, N., et al.[2022]
In a study of 70 patients with acanthosis nigricans (AN) and acrochordon, 41.4% showed insulin resistance (IR), significantly higher than the 17.1% in the control group, indicating a strong association between these skin conditions and IR.
The mean HOMA-IR value was also significantly higher in patients with AN and acrochordon (4.32) compared to controls (2.27), suggesting that these skin markers may be useful indicators of underlying insulin resistance.
Association of Acanthosis Nigricans and Acrochordon with Insulin Resistance: A Cross-Sectional Hospital-Based Study from North India.Singh, SK., Agrawal, NK., Vishwakarma, AK.[2022]
Acanthosis nigricans and acrochordons are skin conditions that can serve as visible indicators of insulin resistance, making them important for early diagnosis.
Recognizing these skin signs can lead to timely treatment, which is crucial in preventing complications associated with insulin resistance and non-insulin-dependent diabetes.
Association of acanthosis nigricans and skin tags with insulin resistance.Barbato, MT., Criado, PR., Silva, AK., et al.[2019]

Citations

Comparison of metformin versus rosiglitazone in patients with Acanthosis nigricans: a pilot study. [2022]
Association of Acanthosis Nigricans and Acrochordon with Insulin Resistance: A Cross-Sectional Hospital-Based Study from North India. [2022]
Association of acanthosis nigricans and skin tags with insulin resistance. [2019]
Acanthosis nigricans with severe obesity, insulin resistance and hypothyroidism: improvement by diet control. [2017]
Effect of weight loss on insulin sensitivity and intramuscular long-chain fatty acyl-CoAs in morbidly obese subjects. [2019]
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