Relation Between Plasma Vitamin K2 and Glycemic Control and Metabolic Parameters in Type 2 Diabetic Patients.

NCT04387019 | Completed

• 1 other identifier: N-3-2020
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

Conditions

Vitamin k2 in Type 2 DM

Keywords

vitamin k2; type 2 DM; glycemic control

Outcome Measures

Primary Outcomes (1)

• plasma vitamin k2 level

  Plasma vitamin K2 level as ng/ml in type 2 diabetes patients

  3 months

Study Arms (3)

I

30 with uncontrolled type 2 DM patients

Diagnostic Test: blood sampling

II

30 controlled type 2 DM patients

Diagnostic Test: blood sampling

III

30 healthy subjects as a control group

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

blood sampling from peripheral vein

I; II; III

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• Men and women aged 20 to 65 years old with controlled and uncontrolled DM .

You may not qualify if:

• Subjects with hepatic , gastrointestinal or cardiovascular disease
• Subjects with osteoporosis.
• Subjects using vitamin supplements containing vitamin K.
• Subjects using oral anticoagulants.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manial, 11521, Egypt

Location

Related Publications (1)

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.).

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of internal medicine .

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 13, 2020
• Study Start: April 24, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 5, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)