Metabolic Syndrome and Insulin Resistance at Allina
Completed · Phase 2
Conditions studied: Metabolic Syndrome
In brief
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.
Key facts
- Study ID
- NCT01545830
- Run by
- Allina Health System
- People needed
- 84
- Starts
- 2012-03-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2016-09-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Allina Health — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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