Colchicine Has Anti-diabetic Effect

Colchicine Has Anti-diabetic Effect and May be an Option for Type 2 Diabetes Management

Colchicine has antidiabetic effect and may be an option for type 2 diabetes management

Study Overview

• Status: Completed
• Conditions: Treatment Adherence
• Intervention / Treatment: Drug: Colchicine Tablets

Detailed Description

Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years.

The aim of this study was to evaluate colchicine effect on A1C of newly diagnosed type2 diabetes compared to the metformin and control group on diet only.

The first group patients received colchicine 0.5twice daily for 6 months, the second group received metformin 1gm twice daily, the third group patients were on diet only. During the period of treatment, the investigators followed the patients if there were side effects of the drugs used. No side effects were monitored during the period of treatment except for gastric upset in some patients using metformin

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Mahmoud Younis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years.

Description

Inclusion Criteria:

• type 2 diabetes newly diagnosed age 35- 55 years

Exclusion Criteria:

• severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1 on cochicine; The first group patients received colchicine 0.5 twice daily for 6 months	Drug: Colchicine Tablets; colchicine tabletes for 6 months
group 2 on glucophage 1 gm twice daily; second group received glucophage 1gm twice daily for 6 months	Drug: Colchicine Tablets; colchicine tabletes for 6 months
group 3 control; the third group patients were on diet only for 6 months	Drug: Colchicine Tablets; colchicine tabletes for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
colchicine for treatment of type diabetes patients	colchicine tablets .5 mg twice daily for 6 months	6 months

Collaborators and Investigators

• Sponsor: Ministry of Health and Population, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 2, 2020

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (ACTUAL): May 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: type 2 diabetes; inflammatory markers; colchicine
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: ymodmenna@gmail.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No