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NCT03648996 · ClinicalTrials.gov registry record · Phase 2
Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid
A Phase 2 study of Diabetes Mellitus, Type 2 and Hyperuricemia, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03648996: Completed Phase 2 study of Diabetes Mellitus, Type 2 and Hyperuricemia, sponsored by University of Missouri-Columbia.
NCT03648996 is a Phase 2 study of Diabetes Mellitus, Type 2 and Hyperuricemia that has completed, run by University of Missouri-Columbia. The registered enrollment target is 34 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03648996, a Phase 2 study of Diabetes Mellitus, Type 2 and Hyperuricemia, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Three separate interventions will be undertaken with the primary outcome of improving pulse wave velocity. Initially, age and BMI-matched men and post-menopausal women, all with type 2 diabetes, will be treated with allopurinol (20 men, 20 women) for 6 months, in order to reduce serum uric acid (SUA) concentrations relative to placebo (10 men, 10 women). In a second intervention, dietary fructose will be restricted for a period of 6 months in type 2 diabetes (T2D) subjects who will maintain a stable weight (20 men, 20 women). In a third intervention, dietary fructose will be restricted for a period of 6 months in type 2 diabetes (T2D) subjects who will achieve a caloric deficit and weight reduction (20 men, 20 women). At the beginning and end of each of the studies, measures of arterial stiffness will be combined with assessments of endothelial function (flow-mediated dilation and insulin stimulated leg blood flow), measurements of systemic inflammation and oxidative stress.
Primary Outcome
It is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Allopurinol
- OTHER Low-fructose diet, isocaloric
- OTHER Low-fructose, hypocaloric
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2022-03-10 |
| Phase | Phase 2 |
What the finished NCT03648996 record still lists
NCT03648996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03648996 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03648996 about?
NCT03648996 is a clinical study titled "Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid". Three separate interventions will be undertaken with the primary outcome of improving pulse wave velocity. Initially, age and BMI-matched men and post-menopausal women, all with type 2 diabetes, will be treated with allopurinol (20 men, 20 women) for 6 months, in order to reduce serum uric acid (SUA...
What is the current status of trial NCT03648996?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2018-11-01. Estimated completion is 2022-03-10.
What conditions does trial NCT03648996 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Hyperuricemia.
What interventions are being tested in trial NCT03648996?
The interventions under investigation include: Placebo (DRUG), Allopurinol (DRUG), Low-fructose diet, isocaloric (OTHER), Low-fructose, hypocaloric (OTHER).
Who is sponsoring clinical trial NCT03648996?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03648996 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03648996's enrollment target sits among peer trials
34 288th of 348 higher than 57 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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