Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

April 6, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the 3rd day of the menstrual cycle
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.
On the 3rd day of the menstrual cycle
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.
On the 3rd day of the menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 6, 2019

First Submitted That Met QC Criteria

April 6, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 6, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.10.22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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