Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial

Methods

Study and population:

This was a randomized controlled clinical trial study conducted at Al-Zafer hospital Najran KSA October 2025. The study received approval from the Institutional Ethics Committee (king Khaled hospital) Najran health cluster KSA on 27 October 2024. IRB registration number with KACST, KSA: H-11-N-136.

Definition of overweight and obesity in adults using Body mass index (BMI): BMI ≥ 25 kg/m² (overweight) and BMI ≥ 30 kg/m² (obesity).

Formula: Body mass index, kg/m2 = weight, kg / (height, m)2 [24] Facts & Figures Simental-Mendia et al. (2008) developed the TyG (Triglyceride-Glucose Index), a mathematical equation that indirectly evaluates IR based on laboratory data: fasting plasma triglycerides and glucose levels [25].

Grouping This study was conducted on a total of 159 participants who attend the outpatient internal medicine clinic.

Group 1: included 53 subjects: 25 non-diabetics and 28 diabetics receiving dulaglutide.

Group 2: included 53 subjects: 25 non-diabetics and 28 diabetics receiving semaglutide.

Group 3: included 53 subjects: 25 non-diabetics and 28 diabetics receiving tirzepatide.

The study will be done from October 2025 to March 2026.

Subject included lithe study:

Inclusion criteria

A minimum of 24 weeks of follow-up was required for adults (18-65 years old) who were either overweight or obese, diabetic, or non-diabetic and had received GLP-1RAs.

Exclusion criteria

In a crossover design, GLP-1RA is compared to other drug classes without a placebo arm or using withdrawn medications. Patients who will refuse to be enrolled in the study or refuse to sign the consent will be also excluded.

Method of selection of sample: the sample will be selected by randomized method.

Sample size: Sample size was calculated using G*Power for a mixed-design ANOVA with two between-subject factors (3×2 design) and one within-subject factor (3 repeated measurements). The total sample size was estimated to be 114 participants, with 19 participants in each group, assuming a medium effect size (f = 0.25) for α = 0.05, power = 99%, and a correlation of 0.5 among repeated measures.

All participants underwent:

Full history taking: with special consideration to age, sex, and location of residence and gastrointestinal symptoms, General examination: The body mass index was determined by dividing the weight (in kilograms) by the square of the height (in meters) with particular attention to weight and height. The Centers for Disease Control and Prevention (CDC) classified individuals with a body mass index (BMI) below 18.5 as underweight. Normal is defined as a body mass index (BMI) between 18.5 and 24.9, 25 to 29.9 is considered overweight, and 30 and above is considered obese), Laboratory investigation: includes fasting blood glucose (FBS), lipid profile TC (Total Cholesterol, Triglycerides (TG), LDL (Low Density Cholesterol), HDL (High Density Cholesterol), liver enzymes (ALT, (Alanine Aminotransferase) AST (Aspartate Aminotransferase), HBA1C using device VITROS product chemistry with LDHI slides kits Ortho-clinical Diagnostics USA and Tyg index (insulin resistance).

Data analysis:

Information was entered and evaluated using IBM-SPSS software for Windows, version 27, 2020, developed by IBM SPSS Inc. in Chicago, Illinois, USA. Numerical data are presented as the median (Q1-Q3), while categorical data are expressed as N (%). Comparisons among groups for numerical variables were conducted using the Kruskal-Wallis H-test, and comparisons for categorical variables were made using the Chi-square test. The correlation between two categorical variables was assessed using a 3-way ANOVA test. A binary outcome variable was predicted based on one or more predictors through binary logistic regression analysis. Statistical significance was defined as a p-value less than 0.05, accompanied by a 95% confidence interval.

Inclusion criteria

• overweight or obese, diabetic, or non-diabetic

Exclusion criteria

• Patients who will refuse to be enrolled in the study or refuse to sign the consent