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

Primary Purpose

Diabete Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Placebo
Vitamin K2
Sponsored by
Dasman Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabete Type 2

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dasman Diabetes InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin K2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Grip Strength
Change in Grip Strength

Secondary Outcome Measures

SPPB
Change in Short Performance Physical Battery Test
HbA1c
Change in glycated haemoglobin
Blood Pressure
Change in blood pressure
Body Mass
Change in body mass
Lean Mass
Change in lean mass
Body Fat
Change in body fat
BMC
Change in bone mineral content
BMD
Change in bone mineral density
Vitamin K status
Change in vitamin K status

Full Information

First Posted
May 11, 2022
Last Updated
July 27, 2023
Sponsor
Dasman Diabetes Institute
Collaborators
Kappa Bioscience
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1. Study Identification

Unique Protocol Identification Number
NCT05375630
Brief Title
Vitamin K2 and Muscle Weakness in Type 2 Diabetes
Acronym
SARK2
Official Title
Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dasman Diabetes Institute
Collaborators
Kappa Bioscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Group Randomised Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
micro-crystalline cellulose placebo (one 380 mg tablet per day)
Arm Title
Vitamin K2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2
Intervention Description
Vitamin K2
Primary Outcome Measure Information:
Title
Grip Strength
Description
Change in Grip Strength
Time Frame
Baseline to one year
Secondary Outcome Measure Information:
Title
SPPB
Description
Change in Short Performance Physical Battery Test
Time Frame
Baseline to one year
Title
HbA1c
Description
Change in glycated haemoglobin
Time Frame
Baseline to one year
Title
Blood Pressure
Description
Change in blood pressure
Time Frame
Baseline to one year
Title
Body Mass
Description
Change in body mass
Time Frame
Baseline to one year
Title
Lean Mass
Description
Change in lean mass
Time Frame
Baseline to one year
Title
Body Fat
Description
Change in body fat
Time Frame
Baseline to one year
Title
BMC
Description
Change in bone mineral content
Time Frame
Baseline to one year
Title
BMD
Description
Change in bone mineral density
Time Frame
Baseline to one year
Title
Vitamin K status
Description
Change in vitamin K status
Time Frame
Baseline to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart Gray
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebaa AlOzairi
Organizational Affiliation
Dasman Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dasman Diabetes Institute
City
Kuwait City
ZIP/Postal Code
15462
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebaa AlOZairi
First Name & Middle Initial & Last Name & Degree
Ebaa AlOzairi

12. IPD Sharing Statement

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Vitamin K2 and Muscle Weakness in Type 2 Diabetes

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