Reactive Oxygen Species in the Pathogenesis of Diabetic Complications
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|ClinicalTrials.gov Identifier: NCT00703989|
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : June 24, 2008
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Dietary Supplement: benfotiamine, α-lipoic acid||Not Applicable|
The glycemic status of study patients was assessed by measuring baseline values of HbA1c, fructosamine, and fasting plasma glucose. Mean HbA1c was 8.7+ 0.7%, mean fructosamine was 421+29 mg/dl (normal range 174-286 mg/dl), and mean fasting blood glucose was 198+44 mg/dl.
At day 0, subjects levels of markers of two benfotiamine-sensitive pathways were determined: intracellular advanced glycation endproduct (AGE) formation, as reflected by a marker of increased intracellular methylglyoxal adducts in endothelial cells, angiopoietin 2 and hexosamine pathway activity, measured by determination of N-acetylglucosamine-modified protein in circulating monocytes. PKC activity in circulating monocytes could not be measured because the amount of blood required exceeded that approved by the Committee on Clinical Investigations. Serum levels of 6-keto-PGF-1 , a stable product produced by the nonenzymatic hydration of the antiatherogenic mediator prostacyclin were also determined. Subjects then took benfotiamine 300 mg twice a day, (Advanced Orthomolecular Research, Calgary, AB,CANADA) and slow-release α-lipoic acid (600 mg twice a day) (MRI, San Francisco, CA) for 28 days. Blood was obtained at day 0, day 15, and day 28.
Data were analyzed using 1-factor analysis of variance to compare the means of all the groups. The Tukey−Kramer multiple comparisons procedure was used to determine which pairs of means were different.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of the Glucosamine Pathway and Reactive Oxygen Species in the Pathogenesis of Diabetic Complications|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||February 2008|
Patients with Type 1 diabetes
Dietary Supplement: benfotiamine, α-lipoic acid
benfotiamine 300 mg twice a day, (Advanced Orthomolecular Research, Calgary, AB,CANADA) and slow-release α-lipoic acid (600 mg twice a day) (MRI, San Francisco, CA) for a total duration of four weeks
No Intervention: II
Age-matched male subjects without Type 1 diabetes
- intracellular advanced glycation endproducts [ Time Frame: four weeks ]
- hexosamine pathway [ Time Frame: four weeks ]
- prostacyclin synthase activity [ Time Frame: four weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703989
|United States, New York|
|GCRC, Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Michael Brownlee, M.D.||Albert Einstein College of Medicine, Inc.|