Flavonoids in the Treatment of Endothelial Dysfunction in Children With Diabetes

NCT01307917 | Withdrawn

• 1 other identifier: A09-3502
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Nephropathy; Endothelial Dysfunction

Keywords

diabetes mellitus; diabetic nephropathy; vascular endothelial dysfunction; flavonoids; flow-mediated dilation

Outcome Measures

Primary Outcomes (1)

• 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.

  day 0; day 14; day 21

Secondary Outcomes (2)

• identify early markers in urine for vascular endothelial injury

  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

  day 0, day 14, day 21

Study Arms (4)

healthy controls high flavonoid

EXPERIMENTAL

20 healthy adolescents (12-21 years old) receiving the flavonoid-rich capsule/supplement

Dietary Supplement: flavonoids

healthy controls low flavonoid

ACTIVE COMPARATOR

20 healthy adolescents (12-21 years old) receiving the placebo

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

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

Dietary Supplement: flavonoids

Interventions

flavonoids DIETARY_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.

T1DM or T2DM high flavonoid; T1DM or T2DM low flavonoid; healthy controls high flavonoid; healthy controls low flavonoid

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus

Interventions

Flavonoids

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tetyana Vasylyeva, MD, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: March 3, 2011
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)