Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

NCT03907618 | Completed

• 1 other identifier: 2018.10.22
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Ovarian Failure

Keywords

Antral follicle count; Anti müllerian hormone; Ovarian reserve; HbA1c; type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Group 1 diagnosed with Diabetes Mellitus

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

Diagnostic Test: ovarian reserve

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

Diagnostic Test: ovarian reserve

Interventions

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.

Group 1 diagnosed with Diabetes Mellitus; group 2 control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Ovarian Reserve

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fertility; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, M.D, Department of Obstetrics and GynecologyR

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 9, 2019
• Study Start: July 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

TU (1)