Diabetes Clinical Trial
Official title:
Evaluation of HbA1c Levels and Ovarian Reserve in Patients With Type 1 Diabetes Diagnosis
NCT number | NCT03907618 |
Other study ID # | 2018.10.22 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | January 1, 2019 |
Verified date | April 2019 |
Source | Kanuni Sultan Suleyman Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kanuni Sultan Süleyman Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Kanuni Sultan Suleyman Training and Research Hospital |
Turkey,
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 |
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