NCT04377321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 2, 2020

Last Update Submit

May 5, 2020

Conditions

Keywords

type 2 diabetescolchicineinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • colchicine for treatment of type diabetes patients

    colchicine tablets .5 mg twice daily for 6 months

    6 months

Study Arms (3)

group 1 on cochicine

The first group patients received colchicine 0.5 twice daily for 6 months

Drug: Colchicine Tablets

group 2 on glucophage 1 gm twice daily

second group received glucophage 1gm twice daily for 6 months

Drug: Colchicine Tablets

group 3 control

the third group patients were on diet only for 6 months

Drug: Colchicine Tablets

Interventions

colchicine tabletes for 6 months

group 1 on cochicinegroup 2 on glucophage 1 gm twice dailygroup 3 control

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • type 2 diabetes newly diagnosed age 35- 55 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Younis

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Treatment Adherence and ComplianceDiabetes Mellitus, Type 2

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 6, 2020

Study Start

October 10, 2019

Primary Completion

May 1, 2020

Study Completion

May 2, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations