Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Supplementation With Vitamins D3 and K2 in Non-carboxyled Osteocalcine and Insulin Serum Levels in Patients With Diabetes Mellitus Type 2
Verified date | July 2019 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Patients with DM2 have chronic hyperglycemia derived from a decrease in insulin
sensitivity, cause of comorbidities such as bone demineralization, decreasing quality of life
and increasing mortality. This could be related to changes in the serum levels of
carboxylated Osteocalcin and Insulin, together with the deficit the daily consumption of
vitamins D3 and K, which is crucial for the process of mineralization of the bone matrix.
Research question: What is the effect of supplementation with Vitamins D3 and K2 on serum
levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus?
Hypothesis: Supplementation with Vitamins D3 and K2 modifies the serum levels of Carboxylated
Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus.
General Objectives: To assess the effect of supplementation with Vitamins D3 and K2 on serum
levels of Carboxylated and Non-Carboxylated Osteocalcin in patients with Type 2 Diabetes
mellitus.
Material and Methods: Clinical trial, double blind, randomization, 40 patients with DM2,
35-65 years, supplementation (3 months), clinical and laboratory determinations (uOC and
Insulin).
- Group 1: Vitamin D3 1000UI + Placebo
- Group 2: Vitamin K2 100 mcg + Placebo
- Group 3 (Positive Control): Vitamins D3 1000UI + K2 100 mcg
Status | Completed |
Enrollment | 100 |
Est. completion date | February 14, 2019 |
Est. primary completion date | February 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Originating and residents of Western Mexico - Both genres - Age of 30-75 years - Diagnosis of DM2 (ADA Criteria) of at least 5 years of evolution - Sign an informed consent letter. Exclusion Criteria: - Use of active drugs for bone mineralization - Pregnancy - Lactation - Creatinine or transaminase more than double the upper limit - Diet added with calcium or vitamins (D, K). |
Country | Name | City | State |
---|---|---|---|
Mexico | Julio Iván Aguayo | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-carboxylated osteocalcin | Serum levels | 3 months | |
Primary | Insulin | Serum levels | 3 months | |
Secondary | Weight | kg | 3 months | |
Secondary | Height | m | 3 months | |
Secondary | Body mass index | Quetelet index | 3 months | |
Secondary | HOMA Index | Insulin resistance | 3 months |
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