Colchicine for Insulin Resistance

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Insulin Resistance+2 More
Colchicine - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

NCT05017571

See full description

Eligible Conditions

  • Insulin Resistance
  • Obesity
  • Inflammation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Colchicine will improve 1 primary outcome and 4 secondary outcomes in patients with Insulin Resistance. Measurement will happen over the course of From baseline to 3 months.

Month 3
Change in High-Sensitivity C-Reactive Protein
Change in Homeostatic model assessment of insulin resistance (HOMA-IR)
Change in Matsuda Index
Change in fasting serum glucose
Change in fasting serum insulin

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Colchicine
Chest pain
1%
Ischemic stroke
1%
Elevated creatinine
0%
Fever
0%
Hemodynamic instabiity
0%
Bleeding
0%
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT01709981) in the Colchicine ARM group. Side effects include: Chest pain with 1%, Ischemic stroke with 1%, Elevated creatinine with 0%, Fever with 0%, Hemodynamic instabiity with 0%.

Trial Design

6 Treatment Groups

Adults no obesity, insulin resistance, or inflammation
1 of 6
Adults with obesity, but no insulin resistance/inflammation
1 of 6
Colchicine - Adolescents
1 of 6
Colchicine - Adults
1 of 6
Placebo - Adolescents
1 of 6
Placebo - Adults
1 of 6
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 500 total participants across 6 different treatment groups

This trial involves 6 different treatments. Colchicine is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Colchicine - Adolescents
Drug
Adolescents given Colchicine 0.6 mg per day (1 capsule per day)
Colchicine - Adults
Drug
Adults given Colchicine 0.6 mg per day (1 capsule per day)
Placebo - Adolescents
Drug
Adolescents given Placebo (1 capsule per day)
Adults no obesity, insulin resistance, or inflammationAdults without obesity, insulin resistance or inflammation
Placebo - Adults
Drug
Adults given Placebo (1 capsule per day)
Adults with obesity, but no insulin resistance/inflammationAdults with obesity, but without insulin resistance or inflammation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline to 3 months for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Having a BMI of 30 or greater (for adults) or a BMI that is at or above the 95th percentile for your age and sex (for adolescents) is considered obese by the Centers for Disease Control. show original
This weight is less than or equal to 450 lbs. show original
The subject is willing to be randomized into the study and is able to give consent or assent as required. show original
Subjects should generally take no medications and the use of over-the-counter and prescription medications will be reviewed on a case-by-case basis show original
An age of at least 18 years is required for adults; an age of 12 to less than 18 years is required for adolescents. show original
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. show original
The study participants must be using a highly effective form of contraception for at least one month prior to screening and agree to continue using such a method during study participation. show original
We are looking for participants who have a HOMA-IR score of >= 2.6, which is calculated by taking their fasting glucose level (in mg/dL) and multiplying it by their insulin level (in microIU/mL/ 405) show original
All people are eligible to participate in the competition, regardless of their race, ethnicity, or gender. show original
We are looking for participants with a high level of inflammation, as those with hsCRP above 2.0 mg/L have been shown to have an increased risk for cardiovascular events. show original

Patient Q&A Section

What causes inflammation?

"Inflammatory responses in tissues are often activated by a host attempting to eliminate an infection or to limit other damage caused by an inflammatory stimulus. Inflammation is one of the most common forms of cellular response to an infection or inflammation, and is also involved in both adaptive and innate immunity. In the context of infection, immune activation and inflammation occurs over time as a means to restore innate and adaptive immune functions in response to persistent antigenic stimuli. Both adaptive and innate immune responses may be stimulated by inflammation, and the two are not mutually exclusive." - Anonymous Online Contributor

Unverified Answer

How many people get inflammation a year in the United States?

"In the United States around 0.5% of people with arthritis are under the age of 30, 4% are under 40, and 19% of those diagnosed are over 70. In Europe it is estimated that 7% of the population has some form of inflammatory arthritis, however, only 3–4% of these are under 30 years of age." - Anonymous Online Contributor

Unverified Answer

What is inflammation?

"Inflammation, a physical response, occurs as a defense mechanism, aimed primarily at destroying invading microorganisms that may threaten the host. The body's natural defenses can be overused and result in a wide range of undesirable side effects. As a result, some clinicians use anti-inflammatory agents whenever possible.\n\n- Inflammation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for inflammation?

"There are many medications to treat inflammation, most commonly targeting cytokines with different methods. A combination of medications with a similar mechanism of action produces the greatest benefit. In general, nonpharmaceutical treatment and, preferably, dietary supplements show efficacy for most inflammatory conditions. Dietary supplements should not replace standard treatment, but should be utilized as an adjunct and complement." - Anonymous Online Contributor

Unverified Answer

What are the signs of inflammation?

"Inflammation is associated with many neurological/neural signals. Specifically, inflammation affects the brain, spinal cord, and brainstem. It can effect mood, behavioural, motor and sensory functions, as well as alter appetite." - Anonymous Online Contributor

Unverified Answer

Can inflammation be cured?

"Inflammation is difficult to cure by any means. All treatments should be carefully tailored to the patient and the treatment plan that may be most effective for each case." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets inflammation?

"It is important, because inflammatory processes begin at an early age, and that you may have them even before you feel any signs of a chronic illness. Inflammation is a very common process that occurs in adults and children." - Anonymous Online Contributor

Unverified Answer

What does colchicine usually treat?

"The most frequent side effects in this survey were gastrointestinal, including nausea, abdominal cramps, and diarrhea. Gastrointestinal symptoms were generally mild and tolerable with medication. In one study the side effect that had the greatest impact on patients was joint pain. The frequency of nausea and vomiting decreased with use of colchicine and this was a benefit to patients. Although colchicine significantly improved the symptoms of arthritis for some people, only half of patients improved on the measure that was used." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of colchicine?

"Side effects can be minimized with medication education and routine symptom monitoring. Colchicine can cause a mild nausea, a high heart rate, an irregular or slow heartbeat, feeling uneasy when starting with a new medication and feeling tired. Colchicine can also lower calcium levels, which may cause bone fractures or tooth decay, as well as other serious problems. In rare cases, colchicine may cause allergic reactions or skin irritation. It may also increase the risk of some infections, particularly if taken at the same time as another blood thinner, warfarin, or corticosteroids. More serious and serious infections can occur when people with other allergies run the risk of developing a more serious allergic reaction." - Anonymous Online Contributor

Unverified Answer

Is colchicine typically used in combination with any other treatments?

"We suggest that when colchicine is being used in conjunction with any other treatments, it is prudent to consider the most common side effects of all drugs. Findings from a recent study indicate that there is a potential risk of liver failure if colchicine is used in combination with other drugs that could cause liver dysfunction." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating inflammation?

"Inflammation is now considered to be a central mechanism in MS and its subtypes. Numerous research findings reveal potential opportunities to develop effective and innovative therapies." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of inflammation?

"We conclude that the primary cause of inflammation is a combination of factors from three physiological systems activated (1) in response to bacterial-associated signals (2) because of changes (3) in the composition of peripheral lymphoid tissues by peripheral blood lymphocytes as a result of aging, (4) in patients following the initiation of immunosuppressive regimens, and/or (5) as a consequence of the autoimmune diseases in which they were diagnosed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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