Effect of Vitamins D3 and K2 in uOc and Insulin Serum Levels in Patients With Diabetes Mellitus

July 31, 2019 updated by: Julio Ivan Aguayo Ruiz, University of Guadalajara

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

  1. - 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:

    • Group 1 Vitamin D3 1000UI + Placebo (Calcined Magnesia).
    • Group 2 Vitamin K2 100 mcg + Placebo (Calcined Magnesia).
    • Group 3 (Positive Control) Vitamins D3 1000UI + K2 100 mcg.
  3. - Blood sample collection through Punzocat, which was placed in a red tube, for subsequent centrifugation at 3500rpm x 15 minutes, performing aliquots of the serum obtained and stored at -80 ° C and thus perform the pertinent quantifications of the molecules to study.

  4. - Quantification of serum levels of non-carboxylated Osteocalcin and Insulin

    a) The determinations corresponding to the serum levels of Non-carboxylated Osteocalcin and Insulin were made, both baseline prior to the intervention as well as the final quantification, once the supplementation was finished, by means of the indirect ELISA technique (commercial reagents -Takara were used - for the realization of these determinations), which involved the following process: In a plate the wells were coated with a first antibody, then a wash was performed to remove the excess antibody, after that, the sample in which the antigen was found was added, which was retained in the well after being recognized by the first antibody, a second wash was subsequently made to remove unbound material, then a solution with a second labeled anti-antigen antibody was applied. Thus each antigen molecule was bound to an antibody in the base that kept it fixed and a second antibody for its reaction and labeling. Finally, the plate was introduced into a spectophotometer and the absorbance was measured at a length of 450 nm, for both non-carboxylated Osteocalcin and Insulin.

  5. - The quantification in serum of cholesterol and triglycerides was carried out by using the fully automated random access analyzer equipment for clinical chemistry, model ERBA XL 200.
  6. - The evaluation of the HOMA index was calculated by using the equations HOMA-IR and HOMA-B, for insulin resistance (IR) and Percentage, respectively.
  7. - The daily of adherence to treatment was provided, so that they recorded all those important events that would ensure adequate intake of vitamins, as well as adverse reactions to them, which were evaluated in scheduled appointments, in addition to each The corresponding bottles were delivered consecutively for each of the 3 months of intervention, with the corresponding vitamins for each patient according to their allocation group.
  8. - Finally, in the last visit the results obtained during the whole study were made known to each of the patients.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44730
        • Julio Iván Aguayo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Vitamin D3 1000UI + Placebo (Calcined Magnesia).
Dietary supplement: Supplementation with Vitamin D3 y K2
Supplementation at a dose of 1 capsule every 24 hours x 3 months
Experimental: Group 2
Vitamin K2 100 mcg + Placebo (Calcined Magnesia).
Dietary supplement: Supplementation with Vitamin D3 y K2
Supplementation at a dose of 1 capsule every 24 hours x 3 months
Active Comparator: Group 3
Vitamin D3 1000UI + Vitamin K2 100 mcg
Dietary supplement: Supplementation with Vitamin D3 y K2
Supplementation at a dose of 1 capsule every 24 hours x 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-carboxylated osteocalcin
Time Frame: 3 months
Serum levels
3 months
Insulin
Time Frame: 3 months
Serum levels
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 3 months
kg
3 months
Height
Time Frame: 3 months
m
3 months
Body mass index
Time Frame: 3 months
Quetelet index
3 months
HOMA Index
Time Frame: 3 months
Insulin resistance
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

February 14, 2018

Study Completion (Actual)

February 14, 2019

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2017-1702-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Non-sharable data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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