- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06728501
Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan
December 6, 2024 updated by: Klaus Parhofer, Ludwig-Maximilians - University of Munich
The aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in Turkmenistan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ashgabat, Turkmenistan
- International Center of Surgery and Endocrinology, Ashgabat, Turkmenistan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- type 2 diabetes
Exclusion Criteria:
- type 1 diabetes
- diabetes duration < 1 year
- severe comorbidities
- abuse of alcohol or drugs
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Diabetes education
Patients receive diabetes education
|
Patients receive 5 hours of diabetes education
|
|
No Intervention: Control
Patients receive no diabetes education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in HbA1c
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
December 6, 2024
First Submitted That Met QC Criteria
December 6, 2024
First Posted (Estimated)
December 11, 2024
Study Record Updates
Last Update Posted (Estimated)
December 11, 2024
Last Update Submitted That Met QC Criteria
December 6, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiabetesEducationTurkmenistan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.