Diabetes Mellitus, Type 2NCT06728501
Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan
A study testing Diabetes education in people with Diabetes Mellitus, Type 2, run by Ludwig-Maximilians - University of Munich at 1 site in Turkmenistan.
Trial summary
The aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in Turkmenistan. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkmenistan
- Study dates
- 1 Feb 2022to 31 Jul 2022
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
Who cannot join
- type 1 diabetes
- diabetes duration < 1 year
- severe comorbidities
- abuse of alcohol or drugs
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkmenistan1 site
International Center of Surgery and Endocrinology, Ashgabat, Turkmenistan
Ashgabat
About this study
The aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in Turkmenistan.
Read the detailed description
Diabetes education is not routinely carried out in Turkmenistan. The aim of the study is to investigate whether patients with type 2 diabetes benefit from an International Diabetes Federation (IDF) based education program. Patients will be randomized into a education group and a control group. The education group will receive 4 - 5 hours of education and the control group will only receive general information about diabetes mellitus. After 6 months, it is checked whether the change in the HbA1c value differs between the two groups. Additinal paremeters such as blood pressure, diabetes knowledge and lipids will also be evaluated (secondary parameters).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes educationBehavioural
Patients receive 5 hours of diabetes education
| Study group | Role | What they receive |
|---|---|---|
| Diabetes education | Active comparator | Patients receive diabetes education Receives: Behavioral: Diabetes education |
| Control | No intervention | Patients receive no diabetes education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
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 posted11 Dec 2024
- Study start1 Feb 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Parhofer, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728501
- Sponsor's protocol ID
- DiabetesEducationTurkmenistan
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan
- ClinicalTrials.gov ID
- NCT06728501
- Acronym / sponsor ID
- DiabetesEducationTurkmenistan
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 11 Dec 2024 (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.
The aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in Turkmenistan.
Detailed description
Diabetes education is not routinely carried out in Turkmenistan. The aim of the study is to investigate whether patients with type 2 diabetes benefit from an International Diabetes Federation (IDF) based education program. Patients will be randomized into a education group and a control group. The education group will receive 4 - 5 hours of education and the control group will only receive general information about diabetes mellitus. After 6 months, it is checked whether the change in the HbA1c value differs between the two groups. Additinal paremeters such as blood pressure, diabetes knowledge and lipids will also be evaluated (secondary parameters).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes education | Active comparator | Behavioral: Diabetes educationPatients receive diabetes education |
| Control | No intervention | –Patients receive no diabetes education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes
Key exclusion criteria (5 listed)
- type 1 diabetes
- diabetes duration < 1 year
- severe comorbidities
- abuse of alcohol or drugs
- pregnancy
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 |
|---|---|---|
| Diabetes educationPatients receive 5 hours of diabetes education | Behavioural | Diabetes education |
Primary outcome
Change in HbA1c
Time frame: 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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Diabetes education in people with Diabetes Mellitus, Type 2, run by Ludwig-Maximilians - University of Munich at 1 site in Turkmenistan.
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 5 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 11 Dec 2024. 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 Turkmenistan. 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?
Change in HbA1c (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 11 Dec 2024.