Vitamin K2 and Muscle Weakness in Type 2 Diabetes

Diabete Type 2 Clinical Trial

— SARK2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375630
• Other study ID #: RA HM-2021-015
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: Dasman Diabetes Institute
• Contact: Stuart Gray
• Phone: 01413302569
• Email: stuart.gray[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Muscle Weakness
• Paresis

Intervention

Dietary Supplement:
• Placebo
Placebo
• Vitamin K2
Vitamin K2

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Kuwait City

Sponsors (2)

Lead Sponsor	Collaborator
Dasman Diabetes Institute	Kappa Bioscience

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip Strength	Change in Grip Strength	Baseline to one year
Secondary	SPPB	Change in Short Performance Physical Battery Test	Baseline to one year
Secondary	HbA1c	Change in glycated haemoglobin	Baseline to one year
Secondary	Blood Pressure	Change in blood pressure	Baseline to one year
Secondary	Body Mass	Change in body mass	Baseline to one year
Secondary	Lean Mass	Change in lean mass	Baseline to one year
Secondary	Body Fat	Change in body fat	Baseline to one year
Secondary	BMC	Change in bone mineral content	Baseline to one year
Secondary	BMD	Change in bone mineral density	Baseline to one year
Secondary	Vitamin K status	Change in vitamin K status	Baseline to one year