Metabolic Syndrome and Insulin Resistance at Allina

NCT01545830 | Completed Phase 2

• 1 other identifier: SPA ID 3607
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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. 1.reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular disease,
2. 2.stabilize or reverse the stage of pre-diabetes,
3. 3.improve quality of life, and,
4. 4.improve the ability to make health-related behavioral changes.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Insulin resistance; Vitamin D deficiency

Outcome Measures

Primary Outcomes (3)

• insulin resistance score by NMR lipid fractionation

  additional insulin resistance measure

  6 months

• 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

• 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

Secondary Outcomes (17)

• 25-OH-vitamin D

  6 months

• fasting lipid profile

  6 months

• adiposity markers

  6 months

• TNF-alpha

  6 months

• weight

  6 months

Study Arms (2)

Regular Dose

ACTIVE COMPARATOR

Intervention: 600 IUs of cholecalciferol taken by mouth daily.

Dietary Supplement: vitamin D3 (cholecalciferol)

High Dose D

EXPERIMENTAL

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

Dietary Supplement: vitamin D3 (cholecalciferol)

Interventions

vitamin D3 (cholecalciferol) 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

Also known as: D-Drops

High Dose D; Regular Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Allina Health

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Gregory Plotnikoff, MD

  Allina Health

  PRINCIPAL INVESTIGATOR

• Jeffery Dusek, PhD

  Allina Health

  STUDY DIRECTOR

• Shaina Biron

  Allina Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Allina Center for Healthcare Research and Innovation

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

US (1)