Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Evaluation of HbA1c Levels and Ovarian Reserve in Patients With Type 1 Diabetes Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907618
• Other study ID #: 2018.10.22
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The human ovary is the target of an autoimmune attack, usually in organ or non-specific autoimmune disorders. Serum anti-Müllerian hormone (AMH) levels decrease early in menopause and menopause is seen in women with type 1 diabetes mellitus (DM1) at a young age. DM1 is aimed to show DM1 relationship with ovarian reserve based on the assumption that it will have lower AMH levels than controls, secondary to bad glycemic control and autoimmune attack in women.

Description:

The study was designed prospectively. Ovarian functions in healthy volunteer women and patients who use DM1 diagnosed between 18-40 years old will be examined. Gonadotropin and AMH levels will be measured in follicular phase. To calculate the number of antral follicles (AFC) and ovarian volume, ultrasound will be looked at. Fasting and satiety blood glucose, HbA1c and C-peptide levels will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• female patients between 18 and 40 years of age who had consent and had gynecological examination in our polyclinic;

• study group for patients with type 1 diabetes mellitus healthy volunteers control group

Exclusion Criteria:

• Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and

• previous surgery, which may reduce ovarian reserves;

• medical and / or radiotherapy

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Ovarian Failure

Intervention

Diagnostic Test:
• ovarian reserve
To assess ovarian reserve in patients with Type 1 Diabetes Mellitus aged 18-40 years; ultrasonographic and laboratory parameters will be looked at.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral follicle count (AFC)	AFC was calculated by counting 2-10 mm diameter follicles in both ovaries with a standard systematic approach.Recorded as a number.	On the 3rd day of the menstrual cycle
Primary	Anti müllerian hormone (AMH)	AMH concentrations were measured by an enzymatically enhanced bilaterally immunoassay. AMH (pmol / l) saved as.	On the 3rd day of the menstrual cycle
Primary	HbA1c	HBA1C concentrations were measured by taking venous blood samples in the early morning hours.; HBA1C (mmol / mol) saved as.	On the 3rd day of the menstrual cycle