Vitamin K2 and Muscle Weakness in Type 2 Diabetes | NCT05375630

Studies
Vitamin K2 and Muscle Weakness in Type 2 Diabetes

NCT05375630

Sponsor

Dasman Diabetes Institute

Status

Unknown status

Last Update Posted

Jul 28, 2023Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Diabete Type 2

Interventions

Placebo
Vitamin K2

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2022Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

May 11, 2022

First Submission Date that Met QC Criteria

May 11, 2022

First Posted Date

May 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2023

Last Update Posted Date

Jul 28, 2023Actual

Name	Class
Kappa Bioscience	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	micro-crystalline cellulose placebo (one 380 mg tablet per day)	Dietary Supplement: Placebo
Vitamin K2	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Placebo	Placebo
Vitamin K2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Grip Strength	Change in Grip Strength	Baseline to one year

Secondary Outcomes

Measure	Description	Time Frame
SPPB	Change in Short Performance Physical Battery Test	Baseline to one year
HbA1c	Change in glycated haemoglobin	Baseline to one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stuart Gray	Contact	01413302569		stuart.gray@glasgow.ac.uk

Overall Officials

Name	Affiliation	Role
Ebaa AlOzairi	Dasman Diabetes Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dasman Diabetes Institute	Recruiting	Kuwait City		15462	Kuwait

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D024482	Vitamin K 2

Ancestor Terms

ID	Term
D014812	Vitamin K
D009285	Naphthoquinones
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided