Clinical Trial Details
| Trial ID: | L4118 |
| Source ID: | NCT06439758 |
| Associated Drug: | Metformin |
| Title: | Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes |
| Acronym: | |
| Status: | NOT_YET_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Type 2|Osteoporosis |
| Interventions: | DRUG: Metformin|BEHAVIORAL: Lifestyle |
| Outcome Measures: | Primary: Changes in bone marker CTX post intervention, Changes in CTX (pg/mL), 6 months|Changes in bone marker PINP post intervention, Changes in PINP (ug/L), 6 months|Changes in bone marker Sclerostin post intervention, Changes in Sclerostin (pmol/L), 6 months|Changes in bone marker Osteocalcin post intervention, Changes in Osteocalcin (ng/mL), 6 months | Secondary: Changes in fasting glucose, urea, and lipid profile post intervention, changes in Lipid profile (HDL, total cholesterol, Triglycerides), Urea, and fasting Glucose (all mmol/L), 6 months|Changes in Creatinine post intervention, Changes in Creatinine (umol/L), 6 months|Changes in Liver profile post intervention, Changes in AST, and ALT (U/L), 6 months |
| Sponsor/Collaborators: | Sponsor: King Saud University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 111 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT |
| Start Date: | 2024-08-01 |
| Completion Date: | 2025-12-01 |
| Results First Posted: | |
| Last Update Posted: | 2024-06-03 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT06439758 |
