Vitamin K2 and Muscle Weakness in Type 2 Diabetes (SARK2)

Dasman Diabetes Institute

Status: Enrolling

Conditions: Diabete Type 2

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin K2

Study type: Interventional

Funder types: Other

Identifiers

NCT05375630

RA HM-2021-015

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

micro-crystalline cellulose placebo (one 380 mg tablet per day)

Treatment:

Dietary Supplement: Placebo

Vitamin K2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin K2