Trial · NCT03648996
Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid
NCT03648996, Phase 2, Completed, University of Missouri-Columbia; results first posted 2023-07-03
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid. Trials, record NCT03648996. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03648996
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid
- NCT number
- NCT03648996
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- University of Missouri-Columbia
- Conditions
- Diabetes Mellitus, Type 2, Hyperuricemia
- Interventions
- Low-fructose diet, isocaloric, Allopurinol, Placebo, Low-fructose, hypocaloric
- First posted
- 2018-08-28
- Last updated
- 2023-07-03
- Results first posted
- 2023-07-03
- Limitations and caveats
- The covid pandemic limited recruitment efforts. Protocol was modified to limit the risk of exposure of research staff and research participants.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Carotid Femoral Pulse Wave Velocity (cfPWV) | This will be assessed at baseline and 6 months (final). The goal is to assess changes from baseline when compared to final time point. | 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 |
| Secondary | Brachial Artery Flow Mediated Dilation (FMD) | Baseline and 6 months (final). The goal is to assess changes from baseline when compared to final time point. | Brachial artery FMD will be assessed at baseline and final. FMD is a measurement of conduit artery endothelial function. FMD is assessed immediately after each PWV measurement. Shear rate AUC until peak diameter is calculated as stimulus for FMD and used in covariate analysis as described. All measurements will be performed, under co-I supervision by the same blinded technician. |
| Secondary | Insulin-stimulated Leg Blood Flow | The goal is to assess insulin stimulated responses in blood flow after 6 mo of intervention. | We will perform a hyperinsulinemic euglycemic clamp to evaluate insulin-stimulated leg blood flow (to be assessed via Doppler ultrasound). Insulin will be infused at a constant rate to mimic postprandial insulin concentrations and glucose maintained at fasting values via a variable 20% dextrose infusion. Femoral artery blood flow will be assessed at the beginning and at end of the 60-minute insulin infusion, and data are presented as percent of change from pre-insulin infusion values. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Carotid Femoral Pulse Wave Velocity (cfPWV) | This will be assessed at baseline and 6 months (final). The goal is to assess changes from baseline when compared to final time point. | Measurement not available for all subjects | m/s | MEAN |
| SECONDARY | Brachial Artery Flow Mediated Dilation (FMD) | Baseline and 6 months (final). The goal is to assess changes from baseline when compared to final time point. | Measurement not available for all subjects | Percentage (%) | MEAN |
| SECONDARY | Insulin-stimulated Leg Blood Flow | The goal is to assess insulin stimulated responses in blood flow after 6 mo of intervention. | The percentage change in blood flow in response to insulin was calculated as femoral blood flow insulin - femoral blood flow insulin no insulin x 100 | Percetage (%) change | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Carotid Femoral Pulse Wave Velocity (cfPWV) | Allopurinol | 8.71 | Standard Deviation 1.47 | m/s | |
| Carotid Femoral Pulse Wave Velocity (cfPWV) | Placebo | 7.8 | Standard Deviation 1.04 | m/s | |
| Carotid Femoral Pulse Wave Velocity (cfPWV) | Low-fructose Diet, Hypocaloric | 8.28 | Standard Deviation 1.40 | m/s | |
| Brachial Artery Flow Mediated Dilation (FMD) | Allopurinol | 5.03 | Standard Deviation 3.44 | Percentage (%) | |
| Brachial Artery Flow Mediated Dilation (FMD) | Placebo | 4.4 | Standard Deviation 2.8 | Percentage (%) | |
| Brachial Artery Flow Mediated Dilation (FMD) | Low-fructose Diet, Hypocaloric | 7.10 | Standard Deviation 2.19 | Percentage (%) | |
| Insulin-stimulated Leg Blood Flow | Allopurinol | -7.68 | Standard Deviation 35.29 | Percetage (%) change | |
| Insulin-stimulated Leg Blood Flow | Placebo | 68.18 | Standard Deviation 153.59 | Percetage (%) change | |
| Insulin-stimulated Leg Blood Flow | Low-fructose Diet, Hypocaloric | 42.65 | Standard Deviation 75.12 | Percetage (%) change |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allopurinol | 9 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | STARTED | Low-fructose Diet, Hypocaloric | 18 | |
| Overall Study | COMPLETED | Allopurinol | 7 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | COMPLETED | Low-fructose Diet, Hypocaloric | 16 | |
| Overall Study | NOT COMPLETED | Allopurinol | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Low-fructose Diet, Hypocaloric | 2 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Allopurinol | 4 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 5 | |
| other | Diarrhea | Gastrointestinal disorders | Low-fructose Diet, Hypocaloric | 0 | 16 | |
| other | Nausea | Gastrointestinal disorders | Allopurinol | 3 | 7 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 5 | |
| other | Nausea | Gastrointestinal disorders | Low-fructose Diet, Hypocaloric | 0 | 16 | |
| other | Skin rash | Skin and subcutaneous tissue disorders | Allopurinol | 2 | 7 | |
| other | Skin rash | Skin and subcutaneous tissue disorders | Placebo | 2 | 5 | |
| other | Skin rash | Skin and subcutaneous tissue disorders | Low-fructose Diet, Hypocaloric | 0 | 16 | |
| other | Non severe hypoglycemia | Endocrine disorders | Allopurinol | 0 | 7 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allopurinol | 0 | 7 |
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, all-cause mortality | Low-fructose Diet, Hypocaloric | 0 | 16 |
| Total, other adverse events | Allopurinol | 5 | 7 |
| Total, other adverse events | Placebo | 4 | 5 |
| Total, other adverse events | Low-fructose Diet, Hypocaloric | 8 | 16 |
| Total, serious adverse events | Allopurinol | 0 | 7 |
| Total, serious adverse events | Placebo | 0 | 5 |
| Total, serious adverse events | Low-fructose Diet, Hypocaloric | 1 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03648996
GET https://conductscience.org/api/trials/v1/NCT03648996/events?page=2