Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

Completed

• Conditions: Diabetes; Ovarian Failure
• Interventions: Diagnostic Test: ovarian reserve

• Registration Number: NCT03907618
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-06
• Study First Submitted QC: 2019-04-06
• Last Update Submitted: 2019-04-06
• Study First Posted: 2019-04-09
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

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Exclusion Criteria

• Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and
• previous surgery, which may reduce ovarian reserves;
• medical and / or radiotherapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 2 control group	ovarian reserve	Healthy volunteer patients aged 18-40 years who have no diagnosis of Type 1 Diabetes Mellitus and whose ovarian reserve is evaluated by gynecological examination
Group 1 diagnosed with Diabetes Mellitus	ovarian reserve	Patients with Type 1 Diabetes Mellitus aged 18-40 years who had ovarian reserve with gynecological examination

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey