Vitamin k2 in Type 2 DMNCT04387019
Relation Between Plasma Vitamin K2 and Glycemic Control and Metabolic Parameters in Type 2 Diabetic Patients.
An observational study of Vitamin k2 in Type 2 DM, run by Cairo University at 1 site in Egypt.
Trial summary
Background and Rationale: The agents inducing type 2 diabetes are yet to be clarified. Current studies show that several genetic and environmental parameters are associated with type 2 diabetes . Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin k2 in Type 2 DM
- What is being tested?
- blood sampling
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Apr 2020to 5 Feb 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - 90 subjects, 60 subjects with type 2 diabetes divided into 30 with uncontrolled type 2 DM patients (group I) and 30 controlled type 2 DM patients (group II) and 30 healthy subjects as a control group (group III).
Who may be able to join
- Men and women aged 20 to 65 years old with controlled and uncontrolled DM .
Who cannot join
- • Subjects with hepatic , gastrointestinal or cardiovascular disease
- Subjects with osteoporosis.
- Subjects using vitamin supplements containing vitamin K.
- Subjects using oral anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Background and Rationale:
The agents inducing type 2 diabetes are yet to be clarified. Current studies show that several genetic and environmental parameters are associated with type 2 diabetes . Vitamin K is emerging as an important micronutrient for its beneficial role in improving insulin sensitivity and glucose metabolism and reducing the risk of type 2 diabetes (T2 D) . Studies demonstrated the lowest prevalence of Metabolic syndrome and its five components among individuals with the highest phylloquinone intake.
Objectives : The aim of our study was to evaluate the relation between plasma vitamin K2 and uncontrolled Type 2 diabetic patients.
Read the detailed description
The frequency of diabetes mellitus is increasing globally and it is expected that this latent disorder will affect 300 million by 2025. Type 2 diabetes mellitus (T2DM) is a metabolic and chronic disease characterized by hyperglycemia representing the major cause of various micro and macrovascular complications
The agents inducing type 2 diabetes are yet to be clarified; however, it has been suggested that diabetes is an immune-dependent disease . Current studies show that several genetic and environmental parameters are associated with type 2 diabetes .
Vitamin K is a fat soluble vitamin . Two vitamin K- dependent-proteins, osteocalcin and matrix gamma carboxy glutamate (Gla ) protein, present in skeletal and vascular system , vitamin K exists mainly in two biologically active forms: vitamin K1 (also known as phylloquinone) and vitamin K2 (also known as menaquinone) .
According to current studies, vitamin K2 has a wider range of effects besides coagulation and functioning as a cofactor for γ--glutamate carboxylase (GGCX ) . The effect on bone is to prevent and treat osteoporosis and the effect on the cardiovascular system is to prevent and treat vascular calcification.
study by Sogabe N et al ., reported an important role of vitamin K in the regulation of dyslipidemia and vitamin K2 treatment delayed the progression of atherosclerotic plaque formation, intima-thickening, and pulmonary atherosclerosis.
study by Dam V et al ., demonstrated the lowest prevalence of Metabolic syndrome and its five components among individuals with the highest phylloquinone intake. Among the five components of Metabolic syndrome , an increase in dietary phylloquinone intake was significantly associated with a decrease in the prevalence of elevated blood pressure and reduced HDL cholesterol .
Vitamin K is emerging as an important micronutrient for its beneficial role in improving insulin sensitivity and glucose metabolism and reducing the risk of type 2 diabetes (T2 D) .
The effect of vitamin K supplementation on insulin sensitivity and glycemic status has been reviewed by study by Manna et al . They integrated currently available evidences and proposed that both vitamin K1 and vitamin K2 supplementation were beneficial to the reduced risk of T2DM. This also suggests a beneficial role of vitamin K2 on insulin sensitivity and glucose metabolism.
studies by (Yan Li et al ., 2018 - Prasenjit Manna And Jatin Kalita , 2016 ) provided an overview of the currently available studies to assess the effect of vitamin K2 supplementation on insulin sensitivity, glycaemic control and reviewed the underlying mechanisms. Overall, carboxylation of vitamin K-dependent protein osteocalcin, anti-inflammatory property, regulation of adipokine levels and lipid-lowering effect were three mechanisms underlying vitamin K2 reduced risk of T2DM and vitamin K2 had a better effect than vitamin K1 on T2DM. The interpretation of this review will increase comprehension of the development of a therapeutic strategy to prevent and treat T2DM.
Objectives:
The aim of our study was to evaluate the relation between plasma vitamin K2 and uncontrolled Type 2 diabetic patients.
Patients and methods:
A case control study including 90 subjects aged 20 to 65 years, 30 healthy subjects as a control group and 60 patients with type 2 DM .Patients will be collected from the endocrinology outpatient clinic, Kasr El Ainy, Cairo university. Patients will be divided into 3 groups, (group I) 30 patients with uncontrolled type 2 DM, (group II) 30 controlled type 2 DM and (group III) 30 non DM as control group.
All subjects will be consented and then subjected to full history taking emphasizing on the age , duration of diabetes mellitus and its treatment and full clinical examination including blood pressure measurement, weight, height, BMI (kg/m2) and waist circumference .
Laboratory investigations : in the form of fasting blood glucose (FBG), 2 hr postprandial blood glucose (2 hr -PPG), fasting lipids {total cholesterol (TC), triglycerides (TAG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C)}, glycosylated hemoglobin (Hb A1c) and Vitamin K 2 levels will be assessed .
laboratory methodology: Two milliliters of peripheral venous blood were collected after 8 hour fasting from each participant. The measurement of Vit K2 was achieved by commercial ELISA kit based on its protocol (Glory science Co., Ltd: U.S.A.).
-Study outcomes:
Primary outcomes :
- Relation between plasma vitamin K2 and glycemic control in Type 2 diabetic patients.
- Relation between plasma vitamin K2 and metabolic parameters in Type 2 diabetic patients.
Secondary outcome parameters :
- Relation between plasma vitamin K2 and disease duration in Type 2 diabetic patients.
- Relation between plasma vitamin K2 and forum of antidiabetic treatment in Type 2 diabetic patients.
- Conditions
- Vitamin k2 in Type 2 DM
- Being tested
- blood sampling
- Keywords
- vitamin k2, type 2 DM, glycemic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
blood sampling from peripheral vein
| Study group | Role | What they receive |
|---|---|---|
| I | 30 with uncontrolled type 2 DM patients Receives: Diagnostic Test: blood sampling | |
| II | 30 controlled type 2 DM patients Receives: Diagnostic Test: blood sampling | |
| III | 30 healthy subjects as a control group Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma vitamin k2 level
Plasma vitamin K2 level as ng/ml in type 2 diabetes patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start24 Apr 2020
- Primary completion1 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin k2 in Type 2 DMStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Youssry Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387019
- Sponsor's protocol ID
- N-3-2020
- Status last verified
- Jun 2021
- First submitted
- 6 May 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: donot share
Publications
o Beulens JW, van der A DL, Grobbee DE et al ., ( 2010 ) . Dietary phylloquinone and menaquinones intakes and risk of type 2 diabetes. Diabetes Care 2010;33:1699-705. o Beulens, Joline WJ, Van Der A, et al ( 2010 ) . Dietary Phylloquinone and Menaquinones Intakes and Risk of Type 2 Diabetes. Diabetes Care. 2010;33:1699-705. o Cruz M, Maldonado-Bernal C, Mondragon-Gonzalez R et al., (2008) .Glycine treatment decreases proinflammatory cytokines and increases interferon-gamma in patients with type 2 diabetes. J Endocrinol Invest.;31:694-699. o Da Silva MS and Rudkowska I ( 2015 ) . Dairy nutrients and their effect on inflammatory profile in molecular studies. Mol Nutr Food Res 2015;59:1249-63. o Dam V, Dalmeijer GW, Vermeer C et al., ( 2015 ) . Association between vitamin k and the metabolic syndromea 10-year follow-up study in adults. J Clin Endocrinol Metab 2015;100:2472-9.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Plasma Vitamin K2 and Glycemic Control and Metabolic Parameters in Type 2 Diabetic Patients.
- ClinicalTrials.gov ID
- NCT04387019
- Acronym / sponsor ID
- N-3-2020
- Conditions
- Vitamin k2 in Type 2 DM
- Keywords
- vitamin k2, type 2 DM, glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 13 May 2020 (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.
Background and Rationale:
The agents inducing type 2 diabetes are yet to be clarified. Current studies show that several genetic and environmental parameters are associated with type 2 diabetes . Vitamin K is emerging as an important micronutrient for its beneficial role in improving insulin sensitivity and glucose metabolism and reducing the risk of type 2 diabetes (T2 D) . Studies demonstrated the lowest prevalence of Metabolic syndrome and its five components among individuals with the highest phylloquinone intake.
Objectives : The aim of our study was to evaluate the relation between plasma vitamin K2 and uncontrolled Type 2 diabetic patients.
Detailed description
The frequency of diabetes mellitus is increasing globally and it is expected that this latent disorder will affect 300 million by 2025. Type 2 diabetes mellitus (T2DM) is a metabolic and chronic disease characterized by hyperglycemia representing the major cause of various micro and macrovascular complications
The agents inducing type 2 diabetes are yet to be clarified; however, it has been suggested that diabetes is an immune-dependent disease . Current studies show that several genetic and environmental parameters are associated with type 2 diabetes .
Vitamin K is a fat soluble vitamin . Two vitamin K- dependent-proteins, osteocalcin and matrix gamma carboxy glutamate (Gla ) protein, present in skeletal and vascular system , vitamin K exists mainly in two biologically active forms: vitamin K1 (also known as phylloquinone) and vitamin K2 (also known as menaquinone) .
According to current studies, vitamin K2 has a wider range of effects besides coagulation and functioning as a cofactor for γ--glutamate carboxylase (GGCX ) . The effect on bone is to prevent and treat osteoporosis and the effect on the cardiovascular system is to prevent and treat vascular calcification.
study by Sogabe N et al ., reported an important role of vitamin K in the regulation of dyslipidemia and vitamin K2 treatment delayed the progression of atherosclerotic plaque formation, intima-thickening, and pulmonary atherosclerosis.
study by Dam V et al ., demonstrated the lowest prevalence of Metabolic syndrome and its five components among individuals with the highest phylloquinone intake. Among the five components of Metabolic syndrome , an increase in dietary phylloquinone intake was significantly associated with a decrease in the prevalence of elevated blood pressure and reduced HDL cholesterol .
Vitamin K is emerging as an important micronutrient for its beneficial role in improving insulin sensitivity and glucose metabolism and reducing the risk of type 2 diabetes (T2 D) .
The effect of vitamin K supplementation on insulin sensitivity and glycemic status has been reviewed by study by Manna et al . They integrated currently available evidences and proposed that both vitamin K1 and vitamin K2 supplementation were beneficial to the reduced risk of T2DM. This also suggests a beneficial role of vitamin K2 on insulin sensitivity and glucose metabolism.
studies by (Yan Li et al ., 2018 - Prasenjit Manna And Jatin Kalita , 2016 ) provided an overview of the currently available studies to assess the effect of vitamin K2 supplementation on insulin sensitivity, glycaemic control and reviewed the underlying mechanisms. Overall, carboxylation of vitamin K-dependent protein osteocalcin, anti-inflammatory property, regulation of adipokine levels and lipid-lowering effect were three mechanisms underlying vitamin K2 reduced risk of T2DM and vitamin K2 had a better effect than vitamin K1 on T2DM. The interpretation of this review will increase comprehension of the development of a therapeutic strategy to prevent and treat T2DM.
Objectives:
The aim of our study was to evaluate the relation between plasma vitamin K2 and uncontrolled Type 2 diabetic patients.
Patients and methods:
A case control study including 90 subjects aged 20 to 65 years, 30 healthy subjects as a control group and 60 patients with type 2 DM .Patients will be collected from the endocrinology outpatient clinic, Kasr El Ainy, Cairo university. Patients will be divided into 3 groups, (group I) 30 patients with uncontrolled type 2 DM, (group II) 30 controlled type 2 DM and (group III) 30 non DM as control group.
All subjects will be consented and then subjected to full history taking emphasizing on the age , duration of diabetes mellitus and its treatment and full clinical examination including blood pressure measurement, weight, height, BMI (kg/m2) and waist circumference .
Laboratory investigations : in the form of fasting blood glucose (FBG), 2 hr postprandial blood glucose (2 hr -PPG), fasting lipids {total cholesterol (TC), triglycerides (TAG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C)}, glycosylated hemoglobin (Hb A1c) and Vitamin K 2 levels will be assessed .
laboratory methodology: Two milliliters of peripheral venous blood were collected after 8 hour fasting from each participant. The measurement of Vit K2 was achieved by commercial ELISA kit based on its protocol (Glory science Co., Ltd: U.S.A.).
-Study outcomes:
Primary outcomes :
- Relation between plasma vitamin K2 and glycemic control in Type 2 diabetic patients.
- Relation between plasma vitamin K2 and metabolic parameters in Type 2 diabetic patients.
Secondary outcome parameters :
- Relation between plasma vitamin K2 and disease duration in Type 2 diabetic patients.
- Relation between plasma vitamin K2 and forum of antidiabetic treatment in Type 2 diabetic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | – | Diagnostic Test: blood sampling30 with uncontrolled type 2 DM patients |
| II | – | Diagnostic Test: blood sampling30 controlled type 2 DM patients |
| III | – | Diagnostic Test: blood sampling30 healthy subjects as a control group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - 90 subjects, 60 subjects with type 2 diabetes divided into 30 with uncontrolled type 2 DM patients (group I) and 30 controlled type 2 DM patients (group II) and 30 healthy subjects as a control group (group III).
Key inclusion criteria (1 listed)
- Men and women aged 20 to 65 years old with controlled and uncontrolled DM .
Key exclusion criteria (4 listed)
- • Subjects with hepatic , gastrointestinal or cardiovascular disease
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 |
|---|---|---|
| blood samplingblood sampling from peripheral vein | Diagnostic test | I, II, III |
Primary outcome
plasma vitamin k2 level
Time frame: 3 months
Plasma vitamin K2 level as ng/ml in type 2 diabetes patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Backgroundo Beulens JW, van der A DL, Grobbee DE et al ., ( 2010 ) . Dietary phylloquinone and menaquinones intakes and risk of type 2 diabetes. Diabetes Care 2010;33:1699-705. o Beulens, Joline WJ, Van Der A, et al ( 2010 ) . Dietary Phylloquinone and Menaquinones Intakes and Risk of Type 2 Diabetes. Diabetes Care. 2010;33:1699-705. o Cruz M, Maldonado-Bernal C, Mondragon-Gonzalez R et al., (2008) .Glycine treatment decreases proinflammatory cytokines and increases interferon-gamma in patients with type 2 diabetes. J Endocrinol Invest.;31:694-699. o Da Silva MS and Rudkowska I ( 2015 ) . Dairy nutrients and their effect on inflammatory profile in molecular studies. Mol Nutr Food Res 2015;59:1249-63. o Dam V, Dalmeijer GW, Vermeer C et al., ( 2015 ) . Association between vitamin k and the metabolic syndromea 10-year follow-up study in adults. J Clin Endocrinol Metab 2015;100:2472-9.
- Individual participant dataSharing planned: No. donot share
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin k2 in Type 2 DM, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jun 2021. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma vitamin k2 level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387019, which also lists 1 linked publication.
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 23 Jun 2021.