Vitamin D and Type 2 Diabetes Study



Status:Active, not recruiting
Conditions:Endocrine, Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - Any
Updated:1/13/2019
Start Date:October 2013
End Date:May 2021

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The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D
supplementation works to delay the onset of type 2 diabetes in people at risk for the disease
and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D
supplementation works to delay the onset of type 2 diabetes in people at risk for the disease
and to gain a better understand how vitamin D affects glucose (sugar) metabolism. Researchers
at US sites will enroll people with pre-diabetes (people who have higher than normal blood
glucose level but not high enough to meet the diagnosis of diabetes). The study will enroll
participants over approximately 2 years and participants will be followed for approximately 3
years. Participants will receive either Vitamin D or a placebo by chance. Participants will
take 1 pill a day for the duration of the study.

Inclusion Criteria:

1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the
following glycemic criteria at the baseline visit:

1. Fasting plasma glucose (FPG) 100-125 mg/dL

2. 2-hour plasma glucose (2hPG) 140-199 mg/dL

3. Hemoglobin A1c (HbA1c) 5.7-6.4%

2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska
Native, Native Hawaiian or Other Pacific Islander).

3. Body Mass Index 22.5 to 42 kg/m2

4. Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria:

1. Diabetes based on either of the following criteria:

1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable
medication approved by the FDA for type 2 diabetes), used for any condition (e.g.
pre-diabetes, diabetes, polycystic ovarian syndrome.

2. Meeting the diagnosis criteria for diabetes

2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.

3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to
become pregnant in the next 4 years or unprotected intercourse. History of gestational
diabetes is not an exclusion criterion.

4. Currently breastfeeding.
We found this trial at
25
sites
Memphis, Tennessee 38163
Principal Investigator: Karen C Johnson, MD, MPH
Phone: 901-448-8400
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Anastassios G Pittas, MD, MS
Phone: 617-636-2842
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Sangeeta Kashyap, MD
Phone: 216-444-3955
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Ranee Chatterjee Montgomery, MD, MPH
Phone: 919-688-7863
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: John Foreyt, PhD
Phone: 713-798-3741
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Anne Peters, MD
Phone: 323-361-8416
University of Southern California The University of Southern California is one of the world’s leading...
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Principal Investigator: Emilia Lao, MD
Phone: 212-420-3450
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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New York, NY
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Neda Rasouli, MD
Phone: 720-848-7710
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Daniel Hsia, MD
Phone: 225-763-3000
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Baton Rouge, LA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Patrick O'Neil, PhD
Phone: 843-792-5427
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Lisa Neff, MD, MS
Phone: 312-503-3413
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Chicago, IL
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Philip Raskin, MD
Phone: 214-342-2383
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Decatur, Georgia 30033
Principal Investigator: Lawrence Phillips, MD
Phone: 404-235-3024
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Decatur, GA
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Hyattsville, Maryland 20782
Principal Investigator: Vanita Aroda, MD
Phone: 301-560-2948
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Hyattsville, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: David C Robbins, MD
Phone: 913-588-6052
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Minneapolis, Minnesota 55454
Principal Investigator: Chhavi Chadha, MD
Phone: 612-341-1950
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Minneapolis, MN
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New Orleans, Louisiana 70112
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Omaha, Nebraska 68105
Principal Investigator: Cyrus Desouza, MBBS
Phone: 402-995-3924
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Omaha, NE
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Cyrus V Desouza, MBBS
Phone: 402-559-6279
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Orlando, Florida 32804
Principal Investigator: Richard E Pratley, MD
Phone: 407-303-7193
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Orlando, Florida 32803
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Palo Alto, California 94304
Principal Investigator: Sun H Kim, MD, MS
Phone: 650-485-3910
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Phoenix, Arizona 85016
Principal Investigator: Jennifer Weil, MD
Phone: 602-640-2190
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Portland, Oregon 97227
Principal Investigator: Erin LeBlanc, MD, MPH
Phone: 503-335-6380
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Scarborough, Maine 04074
Principal Investigator: Irwin Brodsky, Md, MPH
Phone: 207-661-7624
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