Metabolic Syndrome and Insulin Resistance at Allina

NCT ID: NCT01545830

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Regular Dose

Intervention: 600 IUs of cholecalciferol taken by mouth daily.

Group Type: ACTIVE_COMPARATOR

vitamin D3 (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

Active intervention: 6,000 IUs taken by mouth daily for 6 months Active Comparator: 600 IUs taken by mouth daily for 6 months

High Dose D

Intervention: 6,000 IUs of cholecalciferol taken by mouth daily.

Group Type: EXPERIMENTAL

vitamin D3 (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

Active intervention: 6,000 IUs taken by mouth daily for 6 months Active Comparator: 600 IUs taken by mouth daily for 6 months

Interventions

vitamin D3 (cholecalciferol)

Active intervention: 6,000 IUs taken by mouth daily for 6 months Active Comparator: 600 IUs taken by mouth daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

D-Drops

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Jeffery Dusek

Senior Consultant, Allina Center for Healthcare Research and Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory Plotnikoff, MD

Role: PRINCIPAL_INVESTIGATOR

Allina Health

Jeffery Dusek, PhD

Role: STUDY_DIRECTOR

Allina Health

Shaina Biron

Role: STUDY_DIRECTOR

Allina Health

Locations

Allina Health

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

SPA ID 3607

Identifier Type: -

Identifier Source: org_study_id