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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 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.

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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.

Conditions Studied

Diabetes Mellitus, Type 2 Hyperuricemia

Interventions

  • DRUG Placebo
  • DRUG Allopurinol
  • OTHER Low-fructose diet, isocaloric
  • OTHER Low-fructose, hypocaloric

Study Locations (1)

Missouri

  • University of Missouri - Columbia

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2018-11-01
Est. Completion 2022-03-10
Phase Phase 2

Sponsor

University of Missouri-Columbia

291 total trials

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What the Registry Record Tells You About NCT03648996

The ClinicalTrials.gov registry entry for NCT03648996 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.