Vitamin K2 and Muscle Weakness in Type 2 Diabetes (SARK2)

July 27, 2023 updated by: Dr. Ebaa Al Ozairi, Dasman Diabetes Institute

Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

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 Contact

Study Locations

  • Kuwait
      • Kuwait City, Kuwait, 15462
        • Recruiting
        • Dasman Diabetes Institute
        • Contact:
          • Ebaa AlOZairi
        • Principal Investigator:
          • Ebaa AlOzairi

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
micro-crystalline cellulose placebo (one 380 mg tablet per day)
Dietary supplement: Placebo
Placebo
Active Comparator: 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
Dietary supplement: Vitamin K2
Vitamin K2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Baseline to one year
Change in Grip Strength
Baseline to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPPB
Time Frame: Baseline to one year
Change in Short Performance Physical Battery Test
Baseline to one year
HbA1c
Time Frame: Baseline to one year
Change in glycated haemoglobin
Baseline to one year
Blood Pressure
Time Frame: Baseline to one year
Change in blood pressure
Baseline to one year
Body Mass
Time Frame: Baseline to one year
Change in body mass
Baseline to one year
Lean Mass
Time Frame: Baseline to one year
Change in lean mass
Baseline to one year
Body Fat
Time Frame: Baseline to one year
Change in body fat
Baseline to one year
BMC
Time Frame: Baseline to one year
Change in bone mineral content
Baseline to one year
BMD
Time Frame: Baseline to one year
Change in bone mineral density
Baseline to one year
Vitamin K status
Time Frame: Baseline to one year
Change in vitamin K status
Baseline to one year

Collaborators and Investigators

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

Sponsor

Dasman Diabetes Institute

Collaborators

Kappa Bioscience

Investigators

  • Principal Investigator: Ebaa AlOzairi, Dasman Diabetes Institute

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)

March 21, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA HM-2021-015

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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