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The aim of this study is to measure the frequency of menstrual irregularities among adolescent females with Type 1 diabetes mellitus and to assess the therapeutic effect of glucagon-like peptide-1 receptor agonist on menstrual irregularities in adolescent females with Type 1 diabetes mellitus .
All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: this group will only receive conventional insulin therapy. | |
| dulaglutide GROUP | Active Comparator | All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: • Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups:
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Self-Reported Menstrual Irregularities | Number and percentage of participants reporting menstrual irregularities (including oligomenorrhea, amenorrhea, or irregular menstrual cycle length) based on participant self-report. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Self-Reported Menstrual Irregularities | Change from baseline in the number and percentage of participants reporting menstrual irregularities following 3 months of treatment | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Self-Reported Menstrual Cycle Length (days) | Change from baseline in average menstrual cycle length as reported by participants | Baseline to 3 months |
| Number of Participants Reporting Regular Menstrual Cycles |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randa m. Matter, MD | Faculty of Medicine, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Cairo Governorate | 00202 | Egypt | ||
| Ain shams university |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39518671 | Result | Almohareb SN, Alfayez OM, Aljuaid SS, Alshahrani WA, Bakhsh G, Alshammari MK, Al Yami MS, Alshaya OA, Alomran AS, Korayem GB, Almohammed OA. Effectiveness and Safety of GLP-1 Receptor Agonists in Patients with Type 1 Diabetes. J Clin Med. 2024 Oct 30;13(21):6532. doi: 10.3390/jcm13216532. |
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Individual participant data (IPD) will not be shared outside the primary research team.
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All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups:
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|
Self-reported menstrual cycle length between 21 and 35 days
| 3 months |
| Cairo |
| Cairo Governorate |
| 11517 |
| Egypt |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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