Vitamin K2 and Muscle Weakness in Type 2 Diabetes
SARK2
Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2022
CompletedFirst Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJuly 28, 2023
July 1, 2023
2.5 years
May 11, 2022
July 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Grip Strength
Change in Grip Strength
Baseline to one year
Secondary Outcomes (9)
SPPB
Baseline to one year
HbA1c
Baseline to one year
Blood Pressure
Baseline to one year
Body Mass
Baseline to one year
Lean Mass
Baseline to one year
- +4 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORmicro-crystalline cellulose placebo (one 380 mg tablet per day)
Vitamin K2
ACTIVE COMPARATORmicro-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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dasman Diabetes Institutelead
- Kappa Biosciencecollaborator
Study Sites (1)
Dasman Diabetes Institute
Kuwait City, 15462, Kuwait
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ebaa AlOzairi
Dasman Diabetes Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Medical Officer
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 16, 2022
Study Start
March 21, 2022
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
July 28, 2023
Record last verified: 2023-07