Phase 2 Completed N=77 Randomized Quadruple-blind Treatment

Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome

Obesity · Metabolic Syndrome

Source: ClinicalTrials.gov NCT02153983 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcomePrimary: Change in Insulin Sensitivity From FSIVGTT — 0.20; 0.41; -0.45 10^-5*min^-1*mU^-1*mL

Summary

Background: - Being overweight may cause low-level inflammation. This inflammation may cause some of the medical problems of obesity, like high blood sugar (diabetes) and heart disease. This study will test whether a medication called colchicine can improve metabolism in adults who are overweight but have not yet developed diabetes. Objectives: - To learn whether colchicine improves sugar regulation and metabolism. Eligibility: - Healthy overweight adults18 to 100 years old. Design: * Participants must fast before each visit, including the screening visit. * Participants will be screened with blood tests,urine tests, medical history, and physical exam. They will have to drink sugar water, and have blood drawn to find out if they are healthy. * For visit 1, participants will have a medical history and physical exam and answer questions. They will have blood taken with an intravenous (IV) line, give urine sample, and give 2 stool samples.. * Also, subjects will get sugar water through one IV. Blood will be drawn from the other. This measures sugar and insulin levels. During this, participants will lie in a bed and can watch TV. * Participants will have a full-body X-ray, lying on a table while a camera passes over them. They will also have an abdominal CT scan, lying on a table that moves through a ring that takes pictures. * Participants will have a small fat tissue sample taken from their abdomen. It is like getting a mini-liposuction. * Participants will be given the study drug or placebo. They will take it twice daily for 3 months. * For visit 2, participants will have blood tests, urine tests, medical history, and physical exam. * For visit 3, participants will repeat the tests in visit 1.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Insulin Sensitivity From FSIVGTT	0.20; 0.41; -0.45	—
SECONDARY Change in HOMA-IR Index	1.1; -0.3; 8.4	—
SECONDARY Changes in C-reactive Protein	0.5; -2.8; -3.7	—

Eligibility Criteria

INCLUSION CRITERIA FOR SUBJECTS RANDOMIZED TO COLCHICINE or PLACEBO::

Subjects will qualify for randomization to colchicine or placebo if they meet the following criteria:

Good general health. In general subjects should take no medications. However, individuals taking medications for obesity-related co-morbid conditions, who have not had changes in dosage for more than 3 months, may be included, at the discretion of the principal investigator.
Obesity, defined as a body mass index (BMI) greater than or equal to 30 kg/m^2, but weight less than 450 lbs in order for subjects to undergo Dual-Energy X-ray Absorptiometry (DXA) scanning.
Age 18 to 100 years.
Metabolic Syndrome defined as any 3 of the following 5:
FPG greater than or equal to 100 mg/dl, or Impaired Glucose Tolerance (Glucose greater than or equal to 140 mg/dl at 2 hours of OGTT)
Triglycerides greater than or equal to 150 mg/dl, or on treatment
Waist Circumference: Men greater than or equal to 40 in (greater than or equal to 102 cm); Women greater than or equal to 35 in (greater than or equal to 88 cm)
Reduced HDL-C: Men
Type 2 diabetes mellitus that is not well controlled with diet alone: subjects taking an antidiabetic medication (e.g. metformin, insulin, sulfonylureas, etc.) or having a Hemoglobin A1c > 9.0%
Presence of a significant active or chronic illness likely to limit life span and/or increase risk of intervention, including renal (GFR less than or equal to 60 ml/min/1.73m2), cardiovascular, hepatic (other than obesity-related steatosis), gastrointestinal, immunologic, endocrinologic (e.g. Cushing syndrome), pulmonary (other than either asthma not requiring continuous medication or sleep apnea-related disorders), or other disorders at the discretion of the investigators.
Recent use of colchicine or anorexiant medications in the last 3 months.
Females who are pregnant, planning to become pregnant, or are currently nursing an infant.
Individuals who have current substance abuse or a psychiatric disorder or any other condition that in the opinion of the investigators would impede competence, compliance, or participation in the study.
Participation in a formal weight loss program (e.g. Weight Watchers) or recent weight change of more than 3% of body weight in the past two months.
Use of anti-inflammatory medications (e.g. prednisone, NSAIDs) chronically or in the last 7 days prior to fat biopsy.
History of keloid formation.
Current users of tobacco or nicotine products (e.g. nicotine patch, e-cigarettes).

INCLUSION CRITERIA FOR SUBJECTS WITH DIET-CONTROLLED T2DM

Subjects will qualify for the Open Label arm if they meet the following criteria:

A diagnosis of T2DM.
Not on any diabetic/hypoglycemic agents
Not having an alternate cause of hyperglycemia (e.g. T1DM, glucocorticoidinduced, lipodystrophy, acromegaly, etc.)
Hemoglobin A1c less than or equal to 9.0%
Good general health. In general subjects should take no medications. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication or have stopped taking an exclusionary medication for at least 3 months prior to study entry may be eligible
Age greater than or equal to 18 to 100 years.
Obesity, defined as a body mass index (BMI) greater than or equal to 30 kg/m2, but weight less than 450 lbs in order for subjects to undergo Dual-Energy X-ray Absorptiometry (DXA) scanning.
Metabolic Syndrome

(Any 3 of the following 5):

FPG greater than or equal to100 mg/dl or Impaired Glucose Tolerance (Glucose greater than or equal to 140 mg/dl at 2 hours of OGTT)
Triglycerides greater than or equal to 150 mg/dl, or on treatment
Waist Circumference: Men greater than or equal to 40 in (greater than or equal to 102 cm); Women greater than or equal to 35 in (greater than or equal to 88 cm)
Reduced HDL-C: Men 9%.
Presence of a significant

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Data sourced from ClinicalTrials.gov (NCT02153983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.