Diabetic NephropathyflavonoidNCT01307917
Flavonoids in the Treatment of Endothelial Dysfunction in Children With Diabetes
A study testing flavonoids in people with Diabetic Nephropathy and Endothelial Dysfunction, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading complication of diabetes, and attempts to maintain close glycemic control do not prevent the sequelae that claim the lives and quality of life of millions of diabetics each year. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy, Endothelial Dysfunction
- What is being tested?
- flavonoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescents 12 - 21 years old
- with T1DM or T2DM and their healthy age- and sex-matched peers
- DM subjects must maintain good glycemic control with HbA1C < 11
Who cannot join
- no co-morbidities that could lead to inflammation or decline in renal function will be allowed
- no non-steroidal anti-inflammatory drugs should be taken, for any reason, within 48 hours prior to the study days
- no smoking will be permitted on the day of Pre-Study Evaluation or Study Days 0, 14, or 21
- controls should not be taking any medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106
About this study
Official title: Endothelial Dysfunction and the Role of Flavonoids in the Prevention of Nephropathy Among Pediatric Patients With Diabetes
Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading complication of diabetes, and attempts to maintain close glycemic control do not prevent the sequelae that claim the lives and quality of life of millions of diabetics each year. Up to forty percent of patients with diabetes mellitus ultimately develop diabetic nephropathy, the most common cause of end-stage renal disease requiring dialysis in the US. Flavonoid-rich diets are a promising intervention to prevent the endothelial dysfunction that apparently leads to this deadly complication. The mechanisms are still unclear but probably involve nitric oxide synthesis. The investigators hypothesize that early maintenance of the integrity of renal vasculature will significantly improve the lifelong prognosis for patients with diabetes. Flavonoids with anti-inflammatory and antioxidant activities could be used to protect endothelial function, and together with good glycemic control, prevent the development and progression of nephropathy. The investigators aims are to:
- compare endothelial function by studying reactive hyperemia, nitric oxide, and proinflammatory factors in adolescents (12-21 years old) with diabetes versus healthy sex- and age-matched control subjects.
- identify early markers in urine for vascular endothelial injury.
- examine the effects of flavonoids on vascular function, urine nitric oxide, and proinflammatory factors in patients with diabetes mellitus.
Read the detailed description
Our proposal is the first attempt to use flavonoids to treat endothelial dysfunction as a causative factor of nephropathy in a pediatric population with diabetes. The investigators plan to recruit 40 adolescents with type 1 or 2 diabetes mellitus and 40 healthy peers into a double-blind, randomized, controlled study. Peripheral arterial tonometry, a noninvasive method to assess vascular status, will be employed to study endothelial function in both groups. Measurements of renal nitric oxide synthesis will be assayed using a nitric oxide chemiluminescence analyzer. Urinary protein microarray analyses will be conducted to assess early markers of kidney inflammation. The array is a multiplex sandwich fluorescent immunoassay for the simultaneous quantification of interleukin-1b (IL-1b), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, interferon gamma, tumor necrosis factor-alpha, macrophage inflammatory protein-1-alpha and beta, and RANTES. The initial acute response and effect of 14 days of treatment with a flavonoid-rich capsulated supplement will be compared to a placebo. Study subjects will return for baseline assessments a week after the final flavonoid supplement to evaluate the sustainability of the response. Differences between group means for the measured variables before, during, and after the interventions will be tested for statistical significance using paired t-tests and nonparametric statistics. Univariate correlations will be calculated using Pearson's r.
- Conditions
- Diabetic Nephropathy, Endothelial Dysfunction
- Being tested
- flavonoids
- Keywords
- diabetes mellitus, diabetic nephropathy, vascular endothelial dysfunction, flavonoids, flow-mediated dilation
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavonoidsDietary supplement
for 14 days, one dose two times per day, subjects will ingest a flavonoid-rich capsule containing 500 mg flavonoids or a placebo capsule made, stored, and dispensed by TTUHSC Pharmacy, with a similar look and taste.
| Study group | Role | What they receive |
|---|---|---|
| healthy controls high flavonoid | Experimental | 20 healthy adolescents (12-21 years old) receiving the flavonoid-rich capsule/supplement Receives: Dietary Supplement: flavonoids |
| healthy controls low flavonoid | Active comparator | 20 healthy adolescents (12-21 years old) receiving the placebo Receives: Dietary Supplement: flavonoids |
| T1DM or T2DM high flavonoid | Experimental | 20 adolescents (12-21 years old) with Type 1 diabetes mellitus or Type 2 diabetes mellitus receiving the capsule/supplement Receives: Dietary Supplement: flavonoids |
| T1DM or T2DM low flavonoid | Active comparator | 20 adolescents (12-21 years old) with Type 1 diabetes mellitus or Type 2 diabetes mellitus receiving the placebo Receives: Dietary Supplement: flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare endothelial function by studying reactive hyperemia, nitric oxide, and proinflammatory factors in adolescents (12-21 years old) with diabetes vs. healthy sex- and age-matched control subjects.
Measured: day 0; day 14; day 21
Secondary outcomes (2)
identify early markers in urine for vascular endothelial injury
Measured: screening, day 0, day 14, day 21
examine the effects of flavonoids on vascular function, urine nitric oxide, and proinflammatory factors in patients with diabetes mellitus
Measured: day 0, day 14, day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: No funding ever received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tetyana Vasylyeva, MD, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307917
- Sponsor's protocol ID
- A09-3502
- Acronym
- flavonoid
- Status last verified
- Dec 2012
- First submitted
- 15 Nov 2010
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction and the Role of Flavonoids in the Prevention of Nephropathy Among Pediatric Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01307917
- Acronym / sponsor ID
- flavonoid / A09-3502
- Conditions
- Diabetic Nephropathy, Endothelial Dysfunction
- Keywords
- diabetes mellitus, diabetic nephropathy, vascular endothelial dysfunction, flavonoids, flow-mediated dilation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding ever received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading complication of diabetes, and attempts to maintain close glycemic control do not prevent the sequelae that claim the lives and quality of life of millions of diabetics each year. Up to forty percent of patients with diabetes mellitus ultimately develop diabetic nephropathy, the most common cause of end-stage renal disease requiring dialysis in the US. Flavonoid-rich diets are a promising intervention to prevent the endothelial dysfunction that apparently leads to this deadly complication. The mechanisms are still unclear but probably involve nitric oxide synthesis. The investigators hypothesize that early maintenance of the integrity of renal vasculature will significantly improve the lifelong prognosis for patients with diabetes. Flavonoids with anti-inflammatory and antioxidant activities could be used to protect endothelial function, and together with good glycemic control, prevent the development and progression of nephropathy. The investigators aims are to:
- compare endothelial function by studying reactive hyperemia, nitric oxide, and proinflammatory factors in adolescents (12-21 years old) with diabetes versus healthy sex- and age-matched control subjects.
- identify early markers in urine for vascular endothelial injury.
- examine the effects of flavonoids on vascular function, urine nitric oxide, and proinflammatory factors in patients with diabetes mellitus.
Detailed description
Our proposal is the first attempt to use flavonoids to treat endothelial dysfunction as a causative factor of nephropathy in a pediatric population with diabetes. The investigators plan to recruit 40 adolescents with type 1 or 2 diabetes mellitus and 40 healthy peers into a double-blind, randomized, controlled study. Peripheral arterial tonometry, a noninvasive method to assess vascular status, will be employed to study endothelial function in both groups. Measurements of renal nitric oxide synthesis will be assayed using a nitric oxide chemiluminescence analyzer. Urinary protein microarray analyses will be conducted to assess early markers of kidney inflammation. The array is a multiplex sandwich fluorescent immunoassay for the simultaneous quantification of interleukin-1b (IL-1b), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, interferon gamma, tumor necrosis factor-alpha, macrophage inflammatory protein-1-alpha and beta, and RANTES. The initial acute response and effect of 14 days of treatment with a flavonoid-rich capsulated supplement will be compared to a placebo. Study subjects will return for baseline assessments a week after the final flavonoid supplement to evaluate the sustainability of the response. Differences between group means for the measured variables before, during, and after the interventions will be tested for statistical significance using paired t-tests and nonparametric statistics. Univariate correlations will be calculated using Pearson's r.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy controls high flavonoid | Experimental | Dietary Supplement: flavonoids20 healthy adolescents (12-21 years old) receiving the flavonoid-rich capsule/supplement |
| healthy controls low flavonoid | Active comparator | Dietary Supplement: flavonoids20 healthy adolescents (12-21 years old) receiving the placebo |
| T1DM or T2DM high flavonoid | Experimental | Dietary Supplement: flavonoids20 adolescents (12-21 years old) with Type 1 diabetes mellitus or Type 2 diabetes mellitus receiving the capsule/supplement |
| T1DM or T2DM low flavonoid | Active comparator | Dietary Supplement: flavonoids20 adolescents (12-21 years old) with Type 1 diabetes mellitus or Type 2 diabetes mellitus receiving the placebo |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adolescents 12 - 21 years old
- with T1DM or T2DM and their healthy age- and sex-matched peers
- DM subjects must maintain good glycemic control with HbA1C < 11
Key exclusion criteria (4 listed)
- no co-morbidities that could lead to inflammation or decline in renal function will be allowed
- no non-steroidal anti-inflammatory drugs should be taken, for any reason, within 48 hours prior to the study days
- no smoking will be permitted on the day of Pre-Study Evaluation or Study Days 0, 14, or 21
- controls should not be taking any medications
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 |
|---|---|---|
| flavonoidsfor 14 days, one dose two times per day, subjects will ingest a flavonoid-rich capsule containing 500 mg flavonoids or a placebo capsule made, stored, and dispensed by TTUHSC Pharmacy, with a similar look and taste. | Dietary supplement | T1DM or T2DM high flavonoid, T1DM or T2DM low flavonoid, healthy controls high flavonoid, healthy controls low flavonoid |
Primary outcome
compare endothelial function by studying reactive hyperemia, nitric oxide, and proinflammatory factors in adolescents (12-21 years old) with diabetes vs. healthy sex- and age-matched control subjects.
Time frame: day 0; day 14; day 21
2 secondary outcomes
identify early markers in urine for vascular endothelial injury
Time frame: screening, day 0, day 14, day 21
examine the effects of flavonoids on vascular function, urine nitric oxide, and proinflammatory factors in patients with diabetes mellitus
Time frame: day 0, day 14, day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Tetyana Vasylyeva, MD, PhD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flavonoids in people with Diabetic Nephropathy and Endothelial Dysfunction, run by Texas Tech University Health Sciences Center 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 17 Dec 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
compare endothelial function by studying reactive hyperemia, nitric oxide, and proinflammatory factors in adolescents (12-21 years old) with diabetes vs. healthy sex- and age-matched control subjects. (time frame: day 0; day 14; day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2012.