Obesity Clinical Trial
Official title:
Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes
Verified date | November 2019 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Healthy adults between 18 and 65 years old 2. Subject understands the study protocol and agrees to comply with it 3. Informed Consent Form signed by the subject Exclusion Criteria: 1. Subjects using vitamin supplements containing vitamin k 2. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders 3. Subjects presenting chronic degenerative and/or inflammatory diseases 4. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics) 5. Subjects receiving corticosteroid treatment 6. Subjects using oral anticoagulants 7. Subjects with a history of soy allergy 8. Subjects who have participated in a clinical study more recently than one month before the current study |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Georgia; Augusta University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University | Tufts University, University of Alabama at Birmingham, Yale University |
United States,
Booth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13. Review. — View Citation
Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and ß-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24. Erratum in: J Clin Endocrinol Metab. 2016 May;101(5):2265. — View Citation
Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20. — View Citation
Pollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in insulin sensitivity | Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour oral glucose tolerance test by using the oral glucose minimal model. | Change from baseline in insulin sensitivity at 8 weeks | |
Primary | Change in beta-cell function | Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a 2-hour oral glucose tolerance test by using the oral C-peptide minimal model. | Change from baseline in beta-cell function at 8 weeks | |
Secondary | Change in prothrombin time (PT) | Change from baseline in PT at 8 weeks | ||
Secondary | Change in activated partial thromboplastin time (aPTT) | Change from baseline in aPTT at 8 weeks | ||
Secondary | Change in arterial stiffness (PWV) | Arterial stiffness will be assessed using carotid-femoral pulse wave velocity (PWV) by applanation tonometry. | Change from baseline in arterial stiffness at 8 weeks | |
Secondary | Change in endothelial function (FMD) | Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD) by ultrasound. | Change from baseline in endothelial function at 8 weeks |
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