Diabetes Education for Patients With Type 2 Diabetes in T... | NCT06728501

Studies
Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan

NCT06728501

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Dec 11, 2024Actual

Enrollment

114Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

Diabetes education

Countries

Turkmenistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Dec 6, 2024

First Submission Date that Met QC Criteria

Dec 6, 2024

First Posted Date

Dec 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2024

Last Update Posted Date

Dec 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Parhofer, Prof of Endocrinology and Metabolism, Ludwig-Maximilians - University of MunichPrincipal Investigator

Lead Sponsor

Ludwig-Maximilians - University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes education	Active Comparator	Patients receive diabetes education	Behavioral: Diabetes education
Control	No Intervention	Patients receive no diabetes education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diabetes education	Behavioral	Patients receive 5 hours of diabetes education	Diabetes education

Measure	Description	Time Frame
Change in HbA1c		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2 diabetes

Exclusion Criteria:

type 1 diabetes
diabetes duration < 1 year
severe comorbidities
abuse of alcohol or drugs
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Center of Surgery and Endocrinology, Ashgabat, Turkmenistan		Ashgabat			Turkmenistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided