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Vitamin K2 and Muscle Weakness in Type 2 Diabetes

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375630
Acronym
SARK2
Enrollment
150
Registered
2022-05-16
Start date
2022-03-21
Completion date
2024-10-31
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Placebo

DIETARY_SUPPLEMENTVitamin K2

Vitamin K2

Sponsors

Kappa Bioscience
CollaboratorUNKNOWN
Dasman Diabetes Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind

Intervention model description

Parallel Group Randomised Controlled Trial

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Grip StrengthBaseline to one yearChange in Grip Strength

Secondary

MeasureTime frameDescription
SPPBBaseline to one yearChange in Short Performance Physical Battery Test
HbA1cBaseline to one yearChange in glycated haemoglobin
Blood PressureBaseline to one yearChange in blood pressure
Body MassBaseline to one yearChange in body mass
BMDBaseline to one yearChange in bone mineral density
Body FatBaseline to one yearChange in body fat
BMCBaseline to one yearChange in bone mineral content
Vitamin K statusBaseline to one yearChange in vitamin K status
Lean MassBaseline to one yearChange in lean mass

Countries

Kuwait

Contacts

Primary ContactStuart Gray
stuart.gray@glasgow.ac.uk01413302569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026