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NCT05375630 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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