Vitamin K2 and Muscle Weakness in Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Diabete Type 2
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin K2

• Registration Number: NCT05375630
• Lead Sponsor: Dasman Diabetes Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	micro-crystalline cellulose placebo (one 380 mg tablet per day)
Vitamin K2	Vitamin K2	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

Primary Outcome Measures

Name	Time	Method
Grip Strength	Baseline to one year	Change in Grip Strength

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dasman Diabetes Institute; 🇰🇼 Kuwait City, Kuwait