Vitamin K2 and Muscle Weakness in Type 2 Diabetes

NCT ID: NCT05375630

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2024-10-31

Brief Summary

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The aim of the current study is to determine the effects of vitamin K2 supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.

Detailed Description

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Conditions

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Diabete Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Group Randomised Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind

Study Groups

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Placebo

micro-crystalline cellulose placebo (one 380 mg tablet per day)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Vitamin K2

micro-crystalline cellulose (one 380 mg tablet per day) where vitamin K2 (K2VITAL® 0.2% DELTA powder) is mixed into the formulation to a final vitamin K2 concentration of 240 μg/tablet

Group Type ACTIVE_COMPARATOR

Vitamin K2

Intervention Type DIETARY_SUPPLEMENT

Vitamin K2

Interventions

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Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Vitamin K2

Vitamin K2

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Physician confirmed type 2 diabetes.
* Age \>/= 40 years
* No changes in anti-diabetic medication in the last 3 months.
* Muscle weakness (grip strength \<27kg and females \<16kg)

Exclusion Criteria

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* Cancer or cancer that has been in remission \<5 years
* Any medical condition that prevents participants from exercising safely
* On anticoagulant therapy
* Currently consuming vitamin K2 supplements
* Current smoker
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kappa Bioscience

UNKNOWN

Sponsor Role collaborator

Dasman Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ebaa Al Ozairi

Chief Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebaa AlOzairi

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Locations

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Dasman Diabetes Institute

Kuwait City, , Kuwait

Site Status RECRUITING

Countries

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Kuwait

Central Contacts

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Stuart Gray

Role: CONTACT

01413302569

Facility Contacts

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Ebaa AlOZairi

Role: primary

Other Identifiers

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RA HM-2021-015

Identifier Type: -

Identifier Source: org_study_id

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