Flavonoids in the Treatment of Endothelial Dysfunction in Children With Diabetes

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Diabetic Nephropathy, Endothelial Dysfunction

In brief

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: 1. 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. 2. identify early markers in urine for vascular endothelial injury. 3. examine the effects of flavonoids on vascular function, urine nitric oxide, and proinflammatory factors in patients with diabetes mellitus.

Key facts

Study ID

NCT01307917

Run by

Texas Tech University Health Sciences Center

People needed

0

Starts

2009-07-01

Expected to finish

2012-09-01

Last updated by the study team

2012-12-17

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas Tech University Health Sciences Center School of Medicine — Amarillo, Texas, United States

Full record on ClinicalTrials.gov

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