Pre-DiabeticPhase 1NCT04286529

Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons

A Phase 1 study testing Calcitriol capsules in people with Pre-Diabetic, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pre-Diabetic
What is being tested?: Calcitriol capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2020to 28 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) of >24kg/m2
Fasting serum glucose <126 mg/dL

Who cannot join

BMI</=24 kg/m2
Fasting serum glucose >/=126 mg/dL
Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
Serum Calcium >10.2 mg/dL
Serum inorganic phosphorous >4.5mg/dL
Pregnancy or breastfeeding

Show all 20Show fewer

Diagnosis of Diabetes Mellitus
Diagnosis of Rheumatoid Arthritis
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Renal in sufficiency/failure ( serum creatinine >1.5 mg/dL men, > 1.3 mg/dL women)
Chronic active liver disease (bilirubin >1.2 mg/dL, AST>144IU/L, or ALT >165 IU/L)
History of chronic hepatitis
Active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months)
Oral warfarin group medications or history of blood clotting disorders
Platelet count <100,000 per uL within the last 7 days
Alcohol consumption greater than 2 glasses/day or other substance abuse
Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)
Debilitating chronic disease (at the discretion of the investigators)
The presence of infections, highly communicable diseases ( AIDS, active tuberculosis, venereal disease, hepatitis)
Any malignancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Conditions: Pre-Diabetic
Being tested: Calcitriol capsules, Oral Placebo
Keywords: Pre-menopausal women
Medical subject headings: Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcitriol capsulesDrug
0.25micrograms, taken daily for eight weeks, orally
Oral PlaceboDrug
Placebo will be created to mimic the appearance of the study drug

Study groups in NCT04286529
Study group	Role	What they receive
Men-Calcitriol	Active comparator	Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Receives: Drug: Calcitriol capsules
Premenopausal Women-Calcitriol	Active comparator	Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Receives: Drug: Calcitriol capsules
Men-Placebo	Placebo comparator	0.25mcg capsule daily for eight weeks Receives: Drug: Oral Placebo
Premenopausal Women-Placebo	Placebo comparator	0.25mcg capsule daily for eight weeks Receives: Drug: Oral Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose Levels
Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Measured: Baseline and 8 weeks
Insulin Level
Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Measured: Baseline and 8 weeks
C-Peptide Level
Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Measured: Baseline and 8 weeks

Secondary outcomes (1)

PROMIS 10 Questionnaire
Brief 10 question multiple choice survey
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202028 May 2021

First posted27 Feb 2020
Study start1 Oct 2020
Primary completion28 May 2021
Study completion28 May 2021

Why it stopped: Difficulty with study logistics due to COVID-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pre-DiabeticStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04286529
Sponsor's protocol ID: 19-010890
Status last verified: Feb 2022
First submitted: 25 Feb 2020
Last updated: 18 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pre-Diabetic trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
ClinicalTrials.gov ID: NCT04286529
Acronym / sponsor ID: 19-010890
Conditions: Pre-Diabetic
Keywords: Pre-menopausal women
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty with study logistics due to COVID-19
Enrolment: 17 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 28 May 2021 (actual)
Study completion: 28 May 2021 (actual)
First posted: 27 Feb 2020 (actual)
Results: Posted 18 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Men-Calcitriol	Active comparator	Drug: Calcitriol capsulesCalcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Premenopausal Women-Calcitriol	Active comparator	Drug: Calcitriol capsulesCalcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Men-Placebo	Placebo comparator	Drug: Oral Placebo0.25mcg capsule daily for eight weeks
Premenopausal Women-Placebo	Placebo comparator	Drug: Oral Placebo0.25mcg capsule daily for eight weeks

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Body mass index (BMI) of >24kg/m2
Fasting serum glucose <126 mg/dL

Key exclusion criteria (20 listed)

BMI</=24 kg/m2
Fasting serum glucose >/=126 mg/dL
Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
Serum Calcium >10.2 mg/dL
Serum inorganic phosphorous >4.5mg/dL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcitriol capsules0.25micrograms, taken daily for eight weeks, orally	Drug	Men-Calcitriol, Premenopausal Women-Calcitriol
Oral PlaceboPlacebo will be created to mimic the appearance of the study drug	Drug	Men-Placebo, Premenopausal Women-Placebo

Primary outcome

Glucose Levels
Time frame: Baseline and 8 weeks
Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Insulin Level
Time frame: Baseline and 8 weeks
Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
C-Peptide Level
Time frame: Baseline and 8 weeks
Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.

1 secondary outcome

PROMIS 10 Questionnaire
Time frame: 8 weeks

Results and safety

Results posted to the registry on 18 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Men-Calcitriol	4	3
Premenopausal Women-Calcitriol	4	1
Men-Placebo	5	3
Premenopausal Women-Placebo	4	1

Primary outcome: Glucose Levels

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: mg/dL

Measure	Men-Calcitriol n = 3	Premenopausal Women-Calcitriol n = 1	Men-Placebo n = 3	Premenopausal Women-Placebo n = 1
Baseline	90 (4.1)	76 (0)	89 (4)	82 (0)
8 weeks	98 (9.2)	85 (0)	85 (4.7)	–

Population analysed: Data not collected or analyzed at 8 weeks for the one participant in the Premenopausal Women-Placebo study arm.

Primary outcome: Insulin Level

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: uIU/mL

Measure	Men-Calcitriol n = 3	Premenopausal Women-Calcitriol n = 1	Men-Placebo n = 3	Premenopausal Women-Placebo n = 1
Baseline	4.7 (1.8)	4.6 (0)	3 (1.6)	2.4 (0)
8 Weeks	5 (1.8)	4 (0)	3 (0.8)	4 (0)

Primary outcome: C-Peptide Level

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: nmol/L

Measure	Men-Calcitriol n = 3	Premenopausal Women-Calcitriol n = 1	Men-Placebo n = 3	Premenopausal Women-Placebo n = 1
Baseline	0.6 (0.07)	0.5 (0)	0.7 (0.3)	0.5 (0)
8 Weeks	0.74 (0.07)	0.55 (0)	0.49 (0.08)	0.52 (0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline to end of study for a total of approximately 9 weeks on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Men-Calcitriol	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Premenopausal Women-Calcitriol	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Men-Placebo	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Premenopausal Women-Placebo	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Pre-Diabetic

Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rajiv Kumar, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Calcitriol capsules in people with Pre-Diabetic, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose Levels (time frame: Baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04286529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.