Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study)

NCT06347445 | Completed DMC

• 1 other identifier: GSM012024
• Study Type: observational
• Target: 5,707
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey.

Conditions

Diabetes Mellitus

Keywords

glycemic regulation; metabolic control; sleep disorder; sexual dysfunction; depression

Outcome Measures

Primary Outcomes (4)

• Glycemia control status of Turkish adult patients with diabetes mellitus

  Glycemia control will be defined as good control if the mean HbA1c level of patients \< 7% or poor control if the mean HbA1c level of patient between 7% and 9% and very poor control if the mean HbA1c level of patient \> 9%

  7 days

• Blood pressure control status of Turkish adult patients with diabetes mellitus

  Home blood pressure \<135/85 mmHg or office blood pressure \<140/90 mmHg will be defined as under control.

  7 days

• Lipid control status of Turkish adult patients with diabetes mellitus.

  Triglyceride \< 150 mg/dl, LDL-C \<55 mg/dl, \<70 mg/dl and \< 100 mg/dl according to the cardiovascular risk status, HDL-C \> 40 mg/dl for men, and HDL-C \> 50 mg/dl for women will be defined as under control.

  7 days

• Weight control status of Turkish adult patients with diabetes mellitus.

  Body mass index \< 30 kg/m2 will be defined as under control. Weight and height will be combined to report body mass index in kg/m2.

  7 days

Study Arms (1)

Patients with diabetes mellitus

Patients with type 1 or type 2 diabetes who were under follow-up in the same center for at least a year.

Other: There is no intervention.

Interventions

There is no intervention. OTHER

There is no intervention.

Patients with diabetes mellitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 or type 2 diabetes who were under follow-up in the same tertiary endocrine unit for at least a year were enrolled.

You may qualify if:

• Patients with type 1 or type 2 diabetes
• Upper than 18 years old
• To be under follow-up in the same center for at least one year.

You may not qualify if:

• Pregnant or lactation period
• Younger than 18 years old
• History of psychiatric disorders interfering cognition or compliance

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Sleep Wake Disorders; Sexual Dysfunction, Physiological; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Genital Diseases; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Officials

• Alper Sonmez, Prof.

  Ankara Guven Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: October 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)