Diabete Type 2SARK2NCT05375630
Vitamin K2 and Muscle Weakness in Type 2 Diabetes
A study testing Vitamin K2 in people with Diabete Type 2, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Vitamin K2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteKuwait
- Study dates
- 21 Mar 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City, 15462
Ebaa AlOZairi
Ebaa AlOzairi
About this study
Official title: Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
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.
- Conditions
- Diabete Type 2
- Being tested
- Placebo, Vitamin K2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
Vitamin K2Dietary supplement
Vitamin K2
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | micro-crystalline cellulose placebo (one 380 mg tablet per day) Receives: 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 Receives: Dietary Supplement: Vitamin K2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Change in Grip Strength
Measured: Baseline to one year
Secondary outcomes (9)
SPPB
Change in Short Performance Physical Battery Test
Measured: Baseline to one year
HbA1c
Change in glycated haemoglobin
Measured: Baseline to one year
Blood Pressure
Change in blood pressure
Measured: Baseline to one year
Body Mass
Change in body mass
Measured: Baseline to one year
Lean Mass
Change in lean mass
Measured: Baseline to one year
Body Fat
Change in body fat
Measured: Baseline to one year
BMC
Change in bone mineral content
Measured: Baseline to one year
BMD
Change in bone mineral density
Measured: Baseline to one year
Vitamin K status
Change in vitamin K status
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start21 Mar 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group Randomised Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kappa Bioscience
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
- Investigators
- Ebaa AlOzairi, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375630
- Sponsor's protocol ID
- RA HM-2021-015
- Acronym
- SARK2
- Status last verified
- Jul 2023
- First submitted
- 11 May 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05375630
- Acronym / sponsor ID
- SARK2 / RA HM-2021-015
- Conditions
- Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Collaborators
- Kappa Bioscience
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Group Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebomicro-crystalline cellulose placebo (one 380 mg tablet per day) |
| Vitamin K2 | Active comparator | Dietary Supplement: Vitamin K2micro-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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | Placebo |
| Vitamin K2Vitamin K2 | Dietary supplement | Vitamin K2 |
Primary outcome
Grip Strength
Time frame: Baseline to one year
Change in Grip Strength
9 secondary outcomes
SPPB
Time frame: Baseline to one year
HbA1c
Time frame: Baseline to one year
Blood Pressure
Time frame: Baseline to one year
Body Mass
Time frame: Baseline to one year
Lean Mass
Time frame: Baseline to one year
Body Fat
Time frame: Baseline to one year
BMC
Time frame: Baseline to one year
BMD
Time frame: Baseline to one year
Vitamin K status
Time frame: Baseline to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebaa AlOzairi principal investigator
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 in people with Diabete Type 2, run by Dasman Diabetes Institute at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stuart Gray (01413302569, stuart.gray@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Baseline to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.