Treatment AdherenceNCT04377321
Colchicine Has Anti-diabetic Effect
An observational study of Treatment Adherence, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial summary
Colchicine has antidiabetic effect and may be an option for type 2 diabetes management Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Treatment Adherence
- What is being tested?
- Colchicine Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2019to 2 May 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Adult
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.
Who may be able to join
- type 2 diabetes newly diagnosed age 35- 55 years
Who cannot join
- severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Treatment Adherence
- Being tested
- Colchicine Tablets
- Keywords
- type 2 diabetes, colchicine, inflammatory markers
- Medical subject headings
- Treatment Adherence and Compliance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine TabletsDrug
colchicine tabletes for 6 months
| Study group | Role | What they receive |
|---|---|---|
| group 1 on cochicine | The first group patients received colchicine 0.5 twice daily for 6 months Receives: Drug: Colchicine Tablets | |
| group 2 on glucophage 1 gm twice daily | second group received glucophage 1gm twice daily for 6 months Receives: Drug: Colchicine Tablets | |
| group 3 control | the third group patients were on diet only for 6 months Receives: Drug: Colchicine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
colchicine for treatment of type diabetes patients
colchicine tablets .5 mg twice daily for 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start10 Oct 2019
- Primary completion1 May 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mahmoud younis, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377321
- Sponsor's protocol ID
- ymodmenna@gmail.com
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Has Anti-diabetic Effect and May be an Option for Type 2 Diabetes Management
- ClinicalTrials.gov ID
- NCT04377321
- Acronym / sponsor ID
- ymodmenna@gmail.com
- Conditions
- Treatment Adherence
- Keywords
- type 2 diabetes, colchicine, inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colchicine has antidiabetic effect and may be an option for type 2 diabetes management
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 on cochicine | – | Drug: Colchicine TabletsThe first group patients received colchicine 0.5 twice daily for 6 months |
| group 2 on glucophage 1 gm twice daily | – | Drug: Colchicine Tabletssecond group received glucophage 1gm twice daily for 6 months |
| group 3 control | – | Drug: Colchicine Tabletsthe third group patients were on diet only for 6 months |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- type 2 diabetes newly diagnosed age 35- 55 years
Key exclusion criteria (1 listed)
- severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine Tabletscolchicine tabletes for 6 months | Drug | group 1 on cochicine, group 2 on glucophage 1 gm twice daily, group 3 control |
Primary outcome
colchicine for treatment of type diabetes patients
Time frame: 6 months
colchicine tablets .5 mg twice daily for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Adherence, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colchicine for treatment of type diabetes patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.