Metabolic Syndrome and Insulin Resistance at Allina
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2012 |
| End Date: | December 2013 |
| Contact: | Shaina Biron |
| Email: | shaina.biron@allina.com |
| Phone: | 612-863-8936 |
Randomized, Controlled Trial of Vitamin D Replenishment in Metabolic Syndrome
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.
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.
Longitudinal observational studies suggest a significant inverse association between vitamin
D status and both incident and prevalent metabolic syndrome/type II diabetes. Results from
small underpowered trials and post-hoc analyses of data from larger trials designed for
bone-specific outcomes suggest that vitamin D may slow the progression to diabetes in adults
with glucose intolerance. However, at this time, no randomized trials of sufficient size
exist to assess effectiveness.
Importantly, in the investigators' own study of over 10,000 Allina employees, the
investigators found that 6% of these employees had levels less than 10 ng/mL, 30% less than
20 ng/ml and 60% less than 30 ng/ml. Recently, the Intermountain Heart Collaborative Study
Group reviewed 41,504 patient records with at least one measured vitamin D level.
Surprisingly, both the Intermountain and the Allina Employee study demonstrate vitamin D
deficiency (≤30 ng/ml) in more than 60% of people tested with only minor differences by
gender or age (Plotnikoff GA, Finch M, Dusek JA. Impact of Vitamin D Deficiency on the
Productivity of a Health Care Workforce. J Occup Environ Med (in press)).
Furthermore, the Intermountain group demonstrated that vitamin D levels less than 30 ng/ml,
compared to levels greater than 30 ng/ml, were associated with highly significant (p
<0.0001) increases in the prevalence of diabetes, hypertension, hyperlipidemia, and
peripheral vascular disease. Also, those without risk factors but with severe deficiency had
an increased likelihood of developing diabetes, hypertension, and hyperlipidemia. The
vitamin D levels were also highly associated with coronary artery disease, myocardial
infarction, heart failure, and stroke (all p <0.0001), as well as with incident death, heart
failure, coronary artery disease/myocardial infarction (all p <0.0001), stroke (p = 0.003),
and their composite (p <0.0001).
Numerous prevention efforts are underway to minimize the predicted economic and human
burdens from these increasingly common diseases. However, few, if any, prospective clinical
trials are underway with vitamin D interventions. This trial is specifically designed to
prospectively test the impact of vitamin D replenishment on both metabolic syndrome and
insulin resistance.
The 2011 Endocrine Society guidelines assert that vitamin D intakes above the current
recommendations may be associated with better health outcomes. However, there is no
consensus on the optimal 25(OH)D concentration necessary to minimize metabolic syndrome,
insulin resistance and progression to diabetes. This trial is designed to prospectively
identify optimal serum levels for reduction of cardiometabolic risk factors.
D status and both incident and prevalent metabolic syndrome/type II diabetes. Results from
small underpowered trials and post-hoc analyses of data from larger trials designed for
bone-specific outcomes suggest that vitamin D may slow the progression to diabetes in adults
with glucose intolerance. However, at this time, no randomized trials of sufficient size
exist to assess effectiveness.
Importantly, in the investigators' own study of over 10,000 Allina employees, the
investigators found that 6% of these employees had levels less than 10 ng/mL, 30% less than
20 ng/ml and 60% less than 30 ng/ml. Recently, the Intermountain Heart Collaborative Study
Group reviewed 41,504 patient records with at least one measured vitamin D level.
Surprisingly, both the Intermountain and the Allina Employee study demonstrate vitamin D
deficiency (≤30 ng/ml) in more than 60% of people tested with only minor differences by
gender or age (Plotnikoff GA, Finch M, Dusek JA. Impact of Vitamin D Deficiency on the
Productivity of a Health Care Workforce. J Occup Environ Med (in press)).
Furthermore, the Intermountain group demonstrated that vitamin D levels less than 30 ng/ml,
compared to levels greater than 30 ng/ml, were associated with highly significant (p
<0.0001) increases in the prevalence of diabetes, hypertension, hyperlipidemia, and
peripheral vascular disease. Also, those without risk factors but with severe deficiency had
an increased likelihood of developing diabetes, hypertension, and hyperlipidemia. The
vitamin D levels were also highly associated with coronary artery disease, myocardial
infarction, heart failure, and stroke (all p <0.0001), as well as with incident death, heart
failure, coronary artery disease/myocardial infarction (all p <0.0001), stroke (p = 0.003),
and their composite (p <0.0001).
Numerous prevention efforts are underway to minimize the predicted economic and human
burdens from these increasingly common diseases. However, few, if any, prospective clinical
trials are underway with vitamin D interventions. This trial is specifically designed to
prospectively test the impact of vitamin D replenishment on both metabolic syndrome and
insulin resistance.
The 2011 Endocrine Society guidelines assert that vitamin D intakes above the current
recommendations may be associated with better health outcomes. However, there is no
consensus on the optimal 25(OH)D concentration necessary to minimize metabolic syndrome,
insulin resistance and progression to diabetes. This trial is designed to prospectively
identify optimal serum levels for reduction of cardiometabolic risk factors.
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
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