DiabetesNCT03907618
Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes
An observational study of Diabetes and Ovarian Failure, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diabetes, Ovarian Failure
- What is being tested?
- ovarian reserve
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and
- previous surgery, which may reduce ovarian reserves;
- medical and / or radiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Ovarian Failure
- Being tested
- ovarian reserve
- Keywords
- Antral follicle count, Anti müllerian hormone, Ovarian reserve, HbA1c, type 1 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian reserveDiagnostic test
To assess ovarian reserve in patients with Type 1 Diabetes Mellitus aged 18-40 years; ultrasonographic and laboratory parameters will be looked at.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 diagnosed with Diabetes Mellitus | Patients with Type 1 Diabetes Mellitus aged 18-40 years who had ovarian reserve with gynecological examination Receives: 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 Receives: Diagnostic Test: ovarian reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: On the 3rd day of the menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jul 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907618
- Sponsor's protocol ID
- 2018.10.22
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HbA1c Levels and Ovarian Reserve in Patients With Type 1 Diabetes Diagnosis
- ClinicalTrials.gov ID
- NCT03907618
- Acronym / sponsor ID
- 2018.10.22
- Conditions
- Diabetes, Ovarian Failure
- Keywords
- Antral follicle count, Anti müllerian hormone, Ovarian reserve, HbA1c, type 1 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 diagnosed with Diabetes Mellitus | – | Diagnostic Test: ovarian reservePatients with Type 1 Diabetes Mellitus aged 18-40 years who had ovarian reserve with gynecological examination |
| group 2 control group | – | Diagnostic Test: ovarian reserveHealthy volunteer patients aged 18-40 years who have no diagnosis of Type 1 Diabetes Mellitus and whose ovarian reserve is evaluated by gynecological examination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and
- previous surgery, which may reduce ovarian reserves;
- medical and / or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ovarian reserveTo assess ovarian reserve in patients with Type 1 Diabetes Mellitus aged 18-40 years; ultrasonographic and laboratory parameters will be looked at. | Diagnostic test | Group 1 diagnosed with Diabetes Mellitus, group 2 control group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Ovarian Failure, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral follicle count (AFC) (time frame: On the 3rd day of the menstrual cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.