Vitamin D and Type 2 Diabetes - Treat-To-Target

ConditionsPrediabetes Type 2 Diabetes (T2DM)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age30-74

SponsorTufts Medical Center

About this trial

This study tests whether taking a weekly dose of vitamin D, with the dose adjusted to reach a target blood vitamin D level, can help control blood sugar levels in adults at high risk of developing type 2 diabetes (prediabetes).

Research suggests that vitamin D may play a role in blood sugar control. The goal of this study is to see whether adjusting the dose of vitamin D to reach a specific blood vitamin D level improves blood sugar control compared with a placebo (a look-alike pill without vitamin D).

One hundred adults aged 30 to 74 with prediabetes will take part. Participants will be randomly assigned (by chance) to receive either weekly vitamin D supplements or a placebo. Neither the participants nor the research team will know which group a participant is in during the study.

Participants in the vitamin D group will start with one specific dose. After three months, a blood test will be used to decide whether the dose should stay the same or be increased to reach the target vitamin D level. Participants in the placebo group will continue taking the placebo each week.

All participants will be followed for about 18 months. During the study, they will attend scheduled study visits, have blood tests, and wear a continuous glucose monitor, a small device that measures blood sugar levels throughout the day and night. The research team will also make periodic phone calls to check on health changes, medication use, and study participation.

The main outcome of the study is the proportion of time that the participants' blood sugar levels remains in a healthy range.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fasting plasma glucose (FPG) 100-125 mg/dL, inclusive

Hemoglobin A1c (HbA1c) 5.7-6.4%, inclusive

Age 30-74 years, inclusive

Body Mass Index ≥ 23.0 and ≤ 35.0 kg/m2

Disqualifiers

History of diabetes (ICD10 diabetes code E08.X through E13.X) or meeting a diabetes glycemic criterion at screening, as defined by the ADA guidelines (FPG ≥ 126 mg/dL or HbA1c ≥ 6.5%).

History (past 2 years) of hyperparathyroidism, symptomatic or asymptomatic (i.e., radiographic) nephrolithiasis or hypercalcemia.

Any medical condition (past 2 years) that in the opinion of the site investigator may increase risk for nephrolithiasis or hypercalcemia during the trial (e.g., sarcoidosis).

If older than 70 years, history (past 1 year) of a fall.

Trial design

Design model

Parallel

Treatments tested in this trial

Vitamin D (Cholecalciferol )
Drug
Vitamin D (cholecalciferol) will be administered orally once weekly for approximately 18 months. The vitamin D will be provided in liquid form in an ampule. Participants in the intervention group will begin with a dose of 25,000 IU per week. A blood vitamin D level will be measured at 3 months, and the dose will be increased to 50,000 IU per week for participants whose results are below the study target.
Placebo
Drug
Placebo will be administered orally once weekly for approximately 18 months. The placebo will be provided in an ampule and will be matched in appearance, dosing schedule, and duration to the active study medication.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Vitamin DActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Time-in-normoglycemia 140

The cumulative proportion of time that a participant's glucose level is below 140 mg/dL at each CGM measurement period.

Time frame

Assessed every 6 months from enrollment to the end of the study at 18 months.

Time-In-Normoglycemia 126

The cumulative proportion of time that a participant's glucose level is below 126 mg/dL at each CGM measurement period.

Time frame

Assessed every 6 months from enrollment to the end of the study at 18 months.

Secondary outcomes

Mean glycemia (mg/dL)

The average glucose level at each CGM measurement period.

Time frame

Assessed every 6 months from enrollment to the end of the study at 18 months

Glycemic variability

Glycemic variability will be assessed using the mean amplitude of glycemic excursions at each CGM measurement period.

Time frame

Assessed every 6 months from enrollment to the end of the study at 18 months

Hemoglobin A1c (%)

Time frame

Assessed every 6 months from enrollment to the end of the study at 18 months.

Fasting plasma glucose (mg/dL)

Time frame

Assessed every 6 months from enrollment to the end of the study at 18 months.

Other outcomes

Insulin resistance

Insulin resistance by the homeostasis model assessment (HOMA-IR). Higher HOMA-IR values generally indicate greater estimated insulin resistance.

Time frame

Assessed at baseline, 12 months, and 18 months.

Insulin secretion

Insulin secretion by the homeostasis model assessment (HOMA-beta). Higher HOMA beta values generally indicate greater estimated pancreatic β-cell insulin secretion.

Time frame

Assessed from enrollment to the end of study at 18 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts Medical Center

Lead sponsor

Abiogen Pharma

Collaborator

Source ClinicalTrials.gov

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