Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

NCT ID: NCT03907618

Last Updated: 2019-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Diabetes Ovarian Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 diagnosed with Diabetes Mellitus

Patients with Type 1 Diabetes Mellitus aged 18-40 years who had ovarian reserve with gynecological examination

ovarian reserve

Intervention Type 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.

group 2 control group

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

ovarian reserve

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Kadirogulları

principal investigator, M.D, Department of Obstetrics and GynecologyR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018.10.22

Identifier Type: -

Identifier Source: org_study_id

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