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临床试验/NCT04041492
NCT04041492已完成不适用

Effect of Supplementation With Vitamins D3 and K2 in Non-carboxyled Osteocalcine and Insulin Serum Levels in Patients With Diabetes Mellitus Type 2

University of Guadalajara2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Insulin

研究概览

简要总结

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

详细描述

Type 2 diabetes mellitus is a group of metabolic disorders characterized by chronic hyperglycemia, being one of the main causes of mortality in our country.

There are different comorbidities, including bone demineralization, which involve an imbalance in the process of bone formation and resorption, which entails the risk of decreasing bone mineral density. These processes could be related to the serum levels of Non-carboxylated Osteocalcin and Insulin, said molecule locally modulates the process of bone mineralization.

On the other hand, it is known that the daily consumption of vitamins in a general diet in our population (specifically including vitamins D3 and K), is below the necessary basic requirements, so considering crucial elements for the benefit of Bone matrix mineralization, which is why the present study proposes supplementation with the aforementioned vitamins in patients with Type 2 DM, to avoid a decrease in bone mineral density, increasing the mortality rate of individuals suffering from it.

    • The study subjects from the West of the country were invited to participate in the research protocol, where their objective was explained and the signing of the consent was requested under information, where a structured evaluation was subsequently carried out consisting of :

a) Comprehensive clinical evaluation (including general sociodemographic data of a complete medical history). 2. - Once the previous data was obtained, the randomization of the treatment was carried out, classifying the patients in the following groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

randomization simple, double blind.

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Group 1

Experimental

Vitamin D3 1000UI + Placebo (Calcined Magnesia).

干预措施: Supplementation with Vitamin D3 y K2 (Dietary Supplement)

Group 2

Experimental

Vitamin K2 100 mcg + Placebo (Calcined Magnesia).

干预措施: Supplementation with Vitamin D3 y K2 (Dietary Supplement)

Group 3

Active Comparator

Vitamin D3 1000UI + Vitamin K2 100 mcg

干预措施: Supplementation with Vitamin D3 y K2 (Dietary Supplement)

结局指标

主要结局

Insulin

时间窗: 3 months

Serum levels

Non-carboxylated osteocalcin

时间窗: 3 months

Serum levels

次要结局

  • Height(3 months)
  • Body mass index(3 months)
  • HOMA Index(3 months)
  • Weight(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julio Ivan Aguayo Ruiz

Principal Investigator

University of Guadalajara

研究点 (2)

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