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Enrolling by Invitation

NCT Number: NCT07319286

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

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 .

Enrolling by Invitation

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ain shams university, Cairo, Cairo Governorate, Egypt

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About this study

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.
  • Group 2: will only receive conventional insulin therapy. Dulaglutide is an FDA-approved drug in the U.S.; however, this study is conducted entirely outside the United States and is not under an FDA IND.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Type 1 Diabetes Mellitus according to ISPAD criteria
  • Use of continuous glucose monitoring (CGM)
  • Receiving regular insulin therapy
  • Regular follow-up at a diabetes clinic
  • Female participants aged 12 to 18 years
  • At least 2 years post-menarche
  • Poor glycemic control, defined as HbA1c ≥ 7%

Exclusion criteria

  • Presence of medical conditions known to cause menstrual irregularities, including:(Connective tissue disorders, Autoimmune diseases, Clinical thyroid dysfunction, Neurological diseases).
  • History of severe hypoglycemia within the past 12 months
  • Other causes of abnormal uterine bleeding, including:(Structural causes (e.g., leiomyoma, endometrial polyp), Coagulation disorders, Ovulatory disorders (e.g., hyperprolactinemia, hyperandrogenism), Iatrogenic causes (e.g., steroid therapy, oral contraceptive use)
  • Family history of medullary thyroid carcinoma or multiple endocrine neoplasia History of pancreatitis

Treatment and study plan

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:

  • 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.
  • Group 2: will only receive conventional insulin therapy.

Primary outcomes

  1. Frequency of Self-Reported Menstrual Irregularities

    Time frame: Baseline

    Number and percentage of participants reporting menstrual irregularities (including oligomenorrhea, amenorrhea, or irregular menstrual cycle length) based on participant self-report.

Secondary outcomes

  1. Frequency of Self-Reported Menstrual Irregularities

    Time frame: Baseline to 3 months

    Change from baseline in the number and percentage of participants reporting menstrual irregularities following 3 months of treatment

Other outcomes

  1. Change From Baseline in Self-Reported Menstrual Cycle Length (days)

    Time frame: Baseline to 3 months

    Change from baseline in average menstrual cycle length as reported by participants

  2. Number of Participants Reporting Regular Menstrual Cycles

    Time frame: 3 months

    Self-reported menstrual cycle length between 21 and 35 days

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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