Metabolic Syndrome Clinical Trial
— MISURAOfficial title:
Randomized, Controlled Trial of Vitamin D Replenishment in Metabolic Syndrome
Verified date | August 2016 |
Source | Allina Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Vitamin D deficiency is widespread and appears to represent one easily and inexpensively
modifiable risk factor for diabetes and cardiovascular disease. More than 40 years of data
link hypovitaminosis D to metabolic syndrome, insulin resistance, hyperglycemia, type 2
diabetes and increased cardiovascular risk.
Screening for vitamin D deficiency followed by supplementation in appropriate individuals
could be among the simplest and most cost-effective measures for reducing metabolic syndrome
and insulin resistance in the general population.
This study will test the hypothesis that increasing vitamin D status in vitamin D deficient
individuals with metabolic syndrome will:
1. reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular
disease,
2. stabilize or reverse the stage of pre-diabetes,
3. improve quality of life, and,
4. improve the ability to make health-related behavioral changes.
Status | Completed |
Enrollment | 84 |
Est. completion date | March 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Please Note: All participants must be an employee of Allina Health or the spouse of an
Allina employee. Inclusion Criteria: - Vitamin D deficiency, defined as 25-OH vitamin D = 25 ng/ml - Metabolic syndrome as defined by more than three or more of the following: Elevated waist circumference - Men — Equal to or greater than 40 inches - Women — Equal to or greater than 35 inches - Elevated serum triglycerides (=150 mg/dL) - Men — Less than 40 mg/dL - Women — Less than 50 mg/dL - Elevated blood pressure (=130/85 or use of medication for hypertension) - Elevated fasting glucose (=100 mg/dL or use of medication for hyperglycemia) Exclusion Criteria: - Known cardiovascular disease defined as current or prior coronary heart disease, stroke/transient ischemic attack, heart failure, or peripheral vascular disease. - During the study, addition of any medications known to change outcome measures including medications or supplements for hyperlipidemia, hypertension, weight loss, diabetes. - Current Vitamin D supplementation beyond that found in a multivitamin (400 IU) - Current calcium supplementation greater than 600 mg - Untreated blood pressure greater than 159/99 at baseline - Treated blood pressure greater than 150/90 at baseline - Any condition which could limit the ability to complete and comply with 6-month study - Unwillingness or inability to comply with study requirements - Known allergy to coconut or coconut oil |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Allina Health | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Allina Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | insulin resistance score by NMR lipid fractionation | additional insulin resistance measure | 6 months | No |
Primary | Reynolds Risk Score | The Reynolds Risk Score is designed to predict one's risk of having a future heart attack, stroke, or other major heart disease in the next 10 years. In addition to your age, blood pressure, cholesterol levels and whether you currently smoke, the Reynolds Risk Score uses information from two other risk factors, a blood test called hsCRP (a measure of inflammation) and whether or not either of your parents had a heart attack before they reached age 60 (a measure of genetic risk). | 6 months | No |
Primary | Pre-diabetes stage | The pre-diabetes stage, a marker of progression toward type 2 diabetes mellitus, is a calculated score based upon results of fasting adiponectin, insulin and proinsulin. | 6 months | No |
Secondary | 25-OH-vitamin D | 25-OH-vitamin D is the best measure of vitamin D status. | 6 months | Yes |
Secondary | fasting lipid profile | 6 months | No | |
Secondary | adiposity markers | Adiponectin: This adipocyte-derived protein increases hepatic and peripheral insulin sensitivity, moderates fat tissue growth, decreases lipid and glucose production in the liver and suppresses vascular inflammation. This measure declines as insulin resistance increases. Leptin: This adipocyte-derived hormone plays a key role in regulating neuroendocrine and immune function, appetite, metabolic rate and body weight. Many overweight individuals have elevated levels and leptin resistance. |
6 months | No |
Secondary | TNF-alpha | Inflammatory markers: TNF-alpha, IL-6, IL-8. These inflammatory mediators are central to the pathophysiology of obesity and its systemic effects | 6 months | No |
Secondary | weight | 6 months | No | |
Secondary | blood pressure | 6 months | No | |
Secondary | PROMIS-29 | PROMIS is a questionnaire data bank developed and made available by the National Institutes of Health for research purposes. It is used to measure the core domains of physical functioning, fatigue, pain, depression, anxiety, and social role participation. | 6 months | No |
Secondary | Perceived Stress Scale (PSS) | The PSS is brief, validated and widely used psychological instrument for assessing a participant's perception of stress. The PSS-4 consists of 4 questions to measure the degree to which situations in the participant's life are perceived as stressful including questions related to perceived unpredictability and lack of control. | 6 months | No |
Secondary | WPAI | This 6 item, validated instrument measures work and general activity impairment due to health problems. It uses a seven day recall and has been adapted for use in populations with differing health problems. | 6 months | No |
Secondary | PROMIS-GH | PROMIS is a questionnaire data bank developed and made available by the National Institutes of Health for research purposes. The PROMIS-GH consists of 10 items, representing multiple domains and can be scored into a Global Physical Health component and a Global Mental Health component | 6 months | No |
Secondary | International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire (IPAQ) short form (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaire is to provide a common instrument that can be used to obtain internationally comparable data on health related physical activity. The development of this international measure for physical activity commenced in Geneva in 1998 and was followed by extensive reliability and validity testing undertaken in 12 countries (14 sites) across 6 continents during 2000. | 6 months | No |
Secondary | IL-6 | Inflammatory mediators, including IL-6, are central to the pathophysiology of obesity and its systemic effects. | 6 months | No |
Secondary | IL-8 | Inflammatory mediators, inlcuding IL-8, are central to the pathophysiology of obesity and its systemic effects. | 6 months | No |
Secondary | HS-CRP | Elevated HS-CRP predicts the development of type II diabetes and is a crucial factor in calculating the Reynolds Risk Score. | 6 months | No |
Secondary | Lp-PLA2 (PLAC) | This is an enzyme produced by inflammatory cells that hydrolyzes oxidized phospholipids in HDL and catalyzes the degradation of PAF, platelet activating factor. Levels are positively correlated with increased risk of developing coronary artery disease and stroke. | 6 months | No |
Secondary | PAI-1 | This is the primary inhibitor of plasminogen activation. Elevated levels predispose to clot formation by inhibiting fibrinolytic activity. | 6 months | No |
Secondary | Fibrinogen | Fibrinogen is also known as coagulation Factor I. Elevated levels are associated with cardiovascular disease. This is an acute-phase protein that is elevated in any form of inflammation. | 6 months | No |
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