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NOT YET RECRUITING
NCT06439758
PHASE4

Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes

Sponsor: King Saud University

View on ClinicalTrials.gov

Summary

Both diabetes mellitus and osteoporosis are prevalent diseases with crucial associated mortality and morbidity. There is no clear relevance between bone diseases and diabetes mellitus. Previous research indicates that diabetes and complications related to this disease can contribute to bone disease and DM can also determine bone health. Both kinds of diabetes mellitus bring fracture risk, the most substantial clinical osteoporosis endpoint, which has crucial impact on mortality and morbidity including quality of life of an individual. Although research shows that there is association between Type 1 diabetes (T1DM) and decreased bone mineral density (BMD) values, patients with Type 2 diabetes (T2DM) have either normal or higher than expected BMD values usually. General Objective: To determine the influence of first-line anti-DM therapies in bone turnover markers and metabolism among T2DM naïve Saudi adults. Specific objectives: * To investigate the differences in the 3- and 6-month effects of metformin alone, lifestyle intervention alone and combination (metformin + lifestyle modification) on bone markers in T2DM naïve Saudi adults. * To investigate the differences in the 3- and 6-month effects of metformin alone, lifestyle intervention alone and combination (metformin + lifestyle modification) on metabolism in T2DM naïve Saudi adults.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2024-08-01

Completion Date

2025-12-01

Last Updated

2024-06-03

Healthy Volunteers

No

Interventions

DRUG

Metformin

Metformin 1000 mg/day for 6 months

BEHAVIORAL

Lifestyle

Dietary lifestyle modifications