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Enrolling by invitation NCT07319286

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

Phase I / Phase II Interventional Menstrual Irregularities Type1 Diabetes Mellitus Glucagon-Like Peptide-1 Receptor Agonists Female Reproductive Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dulaglutide.
Who it may be relevant to
Registry conditions: Menstrual Irregularities, Type1 Diabetes Mellitus, Glucagon-Like Peptide-1 Receptor Agonists, Female Reproductive Health. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 .

Detailed description

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.

Interventions

  • Drug Dulaglutide
    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 outcome measures

  • Frequency of Self-Reported Menstrual Irregularities [Time frame: Baseline]
Secondary outcome measures (1)
  • Frequency of Self-Reported Menstrual Irregularities [Time frame: Baseline to 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • Ain shams university — Cairo
  • Ain shams university — Cairo

Publications

  • 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. PMID 39518671

Identifiers

NCT: NCT07319286 · FMASU MD142/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗