SARK2: Vitamin K2 and Muscle Weakness in Type 2 Diabetes

• Sponsor: Dasman Diabetes Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05375630
• Collaborator: Kappa Bioscience (Other)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.4
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabete Type 2	Dietary Supplement: Placebo; Dietary Supplement: Vitamin K2	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Group Randomised Controlled TrialParallel Group Randomised Controlled Trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blind
• Primary Purpose: Treatment
• Official Title: Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
• Actual Study Start Date: Mar 21, 2022
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo micro-crystalline cellulose placebo (one 380 mg tablet per day)	Dietary Supplement: Placebo; Placebo
Active Comparator: 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	Dietary Supplement: Vitamin K2; Vitamin K2

Outcome Measures

Primary Outcome Measures

1. Grip Strength [Baseline to one year]

   Change in Grip Strength

Secondary Outcome Measures

1. SPPB [Baseline to one year]

   Change in Short Performance Physical Battery Test

2. HbA1c [Baseline to one year]

   Change in glycated haemoglobin

3. Blood Pressure [Baseline to one year]

   Change in blood pressure

4. Body Mass [Baseline to one year]

   Change in body mass

5. Lean Mass [Baseline to one year]

   Change in lean mass

6. Body Fat [Baseline to one year]

   Change in body fat

7. BMC [Baseline to one year]

   Change in bone mineral content

8. BMD [Baseline to one year]

   Change in bone mineral density

9. Vitamin K status [Baseline to one year]

   Change in vitamin K status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dasman Diabetes Institute	Kuwait City		Kuwait	15462

Sponsors and Collaborators

• Dasman Diabetes Institute
• Kappa Bioscience

Investigators

• Principal Investigator: Ebaa AlOzairi, Dasman Diabetes Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
• ClinicalTrials.gov Identifier: NCT05375630
• Other Study ID Numbers: RA HM-2021-015
• First Posted: May 16, 2022
• Last Update Posted: May 16, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Weakness; Paresis; Diabetes Mellitus, Type 2; Vitamin K; Vitamin K 2

Study Results

No Results Posted as of May 16, 2022