Vitamin D and Type 2 Diabetes Study

Type 2 Diabetes Clinical Trial

— D2d  

Official title:

Vitamin D and Type 2 Diabetes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942694
• Other study ID #: U01DK098245
• Secondary ID: U01DK098245
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: November 2018

Study information

• Verified date: July 2022
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Other known NCT identifiers

• NCT02015052
• NCT02239471

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2423
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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 = 24.0 (22.5 for Asians) and = 42.0 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Prediabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Vitamin D (Cholecalciferol)
Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Other:
• Placebo
Administered as one soft-gel pill daily by mouth

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Tufts Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Duke University	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	MedStar Community Clinical Research Center	Hyattsville	Maryland
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Southern California	Los Angeles	California
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Health Partners Riverside Clinic	Minneapolis	Minnesota
United States	Tulane University Health Sciences	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Omaha VA Medical Center	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital Translational Research Institute	Orlando	Florida
United States	Orlando VA Medical Center	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Southwest American Indian Center	Phoenix	Arizona
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Maine Medical Center	Scarborough	Maine

Sponsors (4)

Lead Sponsor	Collaborator
Tufts Medical Center	American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Sex		Approximately 48 months.
Other	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Ethnicity		Approximately 48 months.
Other	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 2 Hour Plasma Glucose		Approximately 48 months
Other	Time to Development of Cancer.		Approximately 48 months.
Other	Time to Development of Cardiovascular Event.		Approximately 48 months.
Other	Incidence of Cancer in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.		Approximately 48 months.
Other	Incidence of Cardiovascular Disease in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.		Approximately 48 months.
Other	Quality of Life and Mood Scores in Pre-diabetes Population Using a Validated Instrument (PROMIS-29 Profile v2.0 and a General Question on Perception of Overall Health From the PROMIS Scale 1.2).		One time assessment at the month 24 visit.
Primary	Time to Development of Diabetes	New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome.	Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration		Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)	Race and ethnic group were reporting by the participant. The category "other" includes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and other race. Ethnic group includes any race.	Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)	Participants met at least two of three glycemic criteria for prediabetes: fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mmol per liter); plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) (impaired glucose tolerance); and glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mmol per mole).	Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI		Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference		Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age		Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)		Approximately 48 months
Secondary	Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements		Approximately 48 months
Secondary	Blood Plasma 25OHD Concentration.		Approximately 48 months
Secondary	Number of Participants With Adverse Events.		Approximately 48 months
Secondary	Change in Blood Pressure as a Continuous Variable.		Approximately 48 months
Secondary	Number of Participants Who Discontinue Study Pills.		Approximately 48 months
Secondary	Change in FPG as a Continuous Variable.		Every 12 months for approximately 48 months
Secondary	Change in 2hPG as a Continuous Variable.		Every 12 months for approximately 48 months.
Secondary	Change in HbA1c as a Continuous Variable.		Every 6 months for approximately 48 months
Secondary	Measurement of Insulin Resistance (Derived From the OGTT).		Every 12 months for approximately 48 months
Secondary	Measurement of Beta Cell Secretion (Derived From the OGTT)		Every 12 months for approximately 48 months
Secondary	Identification of Characteristics Associated With the Variability in Achieved 25OHD Concentration.		Every 12 months for approximately 48 months