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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04377321
Other study ID # ymodmenna@gmail.com
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2019
Est. completion date May 2, 2020

Study information

Verified date May 2020
Source Ministry of Health and Population, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 2, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers
Gender All
Age group 35 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Colchicine Tablets
colchicine tabletes for 6 months

Locations

Country Name City State
Egypt Mahmoud Younis Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health and Population, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary colchicine for treatment of type diabetes patients colchicine tablets .5 mg twice daily for 6 months 6 months
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