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A prospective randomized controlled trial for exercise and vitamin D in preventing fractures in elderly type 2 diabetic patients

A prospective randomized controlled trial for exercise and vitamin D in preventing fractures in elderly type 2 diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020490
Enrollment
Unknown
Registered
2019-01-02
Start date
2019-02-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

exercise group:comprehensive exercise
vitamin D group:vitamin D3(GNC) 1000IU/day
exercise+vitamin D group:comprehensive exercise and vitamin D3(GNC) 1000IU/day
Control group:none

Sponsors

Tongji Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Men or women aged 65-80 years (including 65 and 80 years old) who signed the informed consent form; (2) patients meets type 2 diabetes criteria issued by WHO (1999) at the time of screening; (3) the t-value of DXA bone density is greater than -2.5; (4) serum 25-hydroxyvitamin D level <75nmol / L at screening; (5) 18.5 kg / m2 < BMI < 35.0 kg / m2 at screening; (6) daily Life does not need to rely on the help of others; (7) in the year before the screening and during the follow-up period, anti-diabetic drugs and life style control were applied to control their blood glucose except for TZDs; (8) agree to maintain the same diet and exercise habits throughout the study, and follow up in time according to the study requirements; (9) willing to sign a written informed consent and abide by the study protocol.

Exclusion criteria

Exclusion criteria: (1) have a history of significant cardiovascular and cerebrovascular diseases, which is defined as: During the first 6 months of screening, subjects had a history of myocardial infarction, coronary angioplasty or bypass, valvular disease or valvular repair, clinically unstable arrhythmia, unstable angina, transient ischemic attack, and cerebrovascular accident; (2) congestive heart failure classified as class III or IV by the New York heart association (NYHA); (3) a history of unstable or rapidly progressive kidney disease; (4) in the active liver disease phase when screening; (5) a clearly diagnosed history of mental illness; (6) have a history of hemoglobinopathy (e.g., sickle cell anemia or thalassemia, iron granulocyte anemia); (7) subjects with low immunity, such as those who have received organ transplantation or have been diagnosed with human immunodeficiency virus infection (such as HIV); (8) any type of malignant tumor (whether cured or not); (9) diseases or drug use that cause secondary osteoporosis; (10) have a history of drug abuse; (11) clinically diagnosed type 1 diabetes, diabetes caused by pancreatic damage or other special types of diabetes; (12) uncontrolled hypertension with antihypertensive drugs (at least 4 weeks) that has been applied at screening (systolic pressure > 160mmHg or diastolic pressure > 100mmHg at screening); (13) patients usually drink 2 units of > every day or 14 units of > every week; One unit of alcohol is equivalent to 150 mL of wine or 350 mL of beer or 100mL of low-alcohol wine (17 degrees or less), 80mL (>17 degrees or 24 degrees or 50 mL of high-alcohol wine (>24 degrees).

Design outcomes

Primary

MeasureTime frame
Fractures at Lumbar, hip;

Secondary

MeasureTime frame
all sites fractures;bone mineral density;short physical performance battery;

Countries

China

Contacts

Public ContactLige Song

Shanghai Tongji Hospital

6songlige@tongji.edu.cn+86 15001831669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026