Effects of First-Line Oral Hypoglycemics in Bone Markers of Treatment Naïve Saudi Adults With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 111
- 主要终点
- Changes in bone marker Osteocalcin post intervention
研究概览
简要总结
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.
详细描述
Design and Setting The present investigation is a multi-center intervention study to be conducted in Hail, Saudi Arabia. The primary endpoint of the study is changes in bone markers.
Participants
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:
Fasting plasma glucose ≥7.0mmol/l or ≥126mg/dl. Fasting is defined as no caloric intake for at least 8 hours OR
• 2-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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •2-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).
排除标准
- •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.
研究组 & 干预措施
Metformin
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose.
干预措施: Metformin (Drug)
Lifestyle
The effect is when a person's physical or mental health appears to improve after changing their diary system.
干预措施: Lifestyle (Behavioral)
结局指标
主要结局
Changes in bone marker Osteocalcin post intervention
时间窗: 6 months
Changes in Osteocalcin (ng/mL)
Changes in bone marker PINP post intervention
时间窗: 6 months
Changes in PINP (ug/L)
Changes in bone marker CTX post intervention
时间窗: 6 months
Changes in CTX (pg/mL)
Changes in bone marker Sclerostin post intervention
时间窗: 6 months
Changes in Sclerostin (pmol/L)
次要结局
- Changes in fasting glucose, urea, and lipid profile post intervention(6 months)
- Changes in Liver profile post intervention(6 months)
- Changes in Creatinine post intervention(6 months)
研究者
Mohammed Ali Almosfer
Principal Investigator
King Saud University