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

Phase 2Enrolling By InvitationNCT07319286

Ain Shams University50 enrolled

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 .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Menstrual Irregularities Type1 Diabetes Mellitus Glucagon-Like Peptide-1 Receptor Agonists

Interventions

DulaglutideDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes