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Completed

NCT Number: NCT03907618

Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Ovarian Failure

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ovarian reserve

Diagnostic Test

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

Primary outcomes

  1. Antral follicle count (AFC)

    Time frame: 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.

  2. Anti müllerian hormone (AMH)

    Time frame: On the 3rd day of the menstrual cycle

    AMH concentrations were measured by an enzymatically enhanced bilaterally immunoassay. AMH (pmol / l) saved as.

  3. HbA1c

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2019
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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