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

NCT06439758 | Not Yet Recruiting Phase 4

• 1 other identifier: IRB log Number: 2024-6
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Type 2; Osteoporosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Changes in fasting glucose, urea, and lipid profile post intervention

  6 months

• Changes in Creatinine post intervention

  6 months

• Changes in Liver profile post intervention

  6 months

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose.

Drug: Metformin

Lifestyle

PLACEBO COMPARATOR

The effect is when a person's physical or mental health appears to improve after changing their diary system.

Behavioral: Lifestyle

Interventions

Metformin DRUG

Metformin 1000 mg/day for 6 months

Metformin

Lifestyle BEHAVIORAL

Dietary lifestyle modifications

Lifestyle

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting Saudi adults, males, and females, aged 25-65 years with newly diagnosed T2DM will be included.
• T2DM diagnosis will be done by collaborating primary care physicians following the American Diabetes Association (ADA) and World Health Organization (WHO) criteria (ADA, 2022):
• Fasting plasma glucose ≥7.0mmol/l or ≥126mg/dl. Fasting is defined as no caloric intake for at least 8 hours OR
• h PG ≥200 mg/dl (11.1 mmol/L) during OGTT. The test should be performed as described by WHO, using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.
• OR •Hba1c ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications (Trial) DCCT assay.
• In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl (11.1 mmol/L).

You may not qualify if:

• Non-Saudis and those outside the age range (less than 25 years and above 65 years old).
• Those with comorbidities and existing complications (osteoporosis, uncontrolled hypertension, atherosclerosis, renal and liver abnormalities, morbidly obese, psychologically incapacitated).
• Known cases of T2DM who are already on medications.
• Participants who will be unable to commit to the treatment allocated for 6 months, either for personal reasons or physician's advice.

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteoporosis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Nassir Mo Al-dagari, PhD

  King Saud

  STUDY DIRECTOR

Central Study Contacts

Mohammed Al Almosfer, PhD

CONTACT

00966540771115; 444105548@student.ksu.edu.sa

Shaun B Sabico, M.D. PhD

CONTACT

00966114675939; ssabico@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 3, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share