NCT00703989

Brief Summary

Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells, it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been reported to reduce both diabetic microvascular and macrovascular complications in animal models. To determine whether benfotiamine in combination with α-lipoic acid would normalize markers of ROS-induced pathways of complications in humans, we performed a pilot study in subjects with Type 1 diabetes using one daily dose of benfotiamine in combination with α-lipoic acid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
Last Updated

November 12, 2019

Status Verified

June 1, 2008

Enrollment Period

1.7 years

First QC Date

June 23, 2008

Last Update Submit

November 8, 2019

Conditions

Type 1 Diabetes

Keywords

hyperglycemiadiabetic complicationsadvanced glycation endproductshexosamine pathwayprostacyclin synthasereactive oxygen species

Outcome Measures

Primary Outcomes (3)

  • intracellular advanced glycation endproducts

    four weeks

  • hexosamine pathway

    four weeks

  • prostacyclin synthase activity

    four weeks

Study Arms (2)

I

EXPERIMENTAL

Patients with Type 1 diabetes

Dietary Supplement: benfotiamine, α-lipoic acid

II

NO INTERVENTION

Age-matched male subjects without Type 1 diabetes

Interventions

benfotiamine, α-lipoic acidDIETARY_SUPPLEMENT

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

Also known as: benfotiamine 300 mg .slow-release, α-lipoic acid (600 mg twice a day)
I

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Type 1 diabetes duration between zero and fifteen years
  • current insulin therapy

You may not qualify if:

  • Female
  • proliferative retinopathy
  • microalbuminuria
  • symptomatic diabetic neuropathy
  • cardiovascular disease
  • taking medications
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GCRC, Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (2)

  • Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. doi: 10.2337/diabetes.54.6.1615. No abstract available.

    PMID: 15919781BACKGROUND

  • Du X, Edelstein D, Brownlee M. Oral benfotiamine plus alpha-lipoic acid normalises complication-causing pathways in type 1 diabetes. Diabetologia. 2008 Oct;51(10):1930-2. doi: 10.1007/s00125-008-1100-2. Epub 2008 Jul 29.

    PMID: 18663426DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1HyperglycemiaDiabetes Complications

Interventions

benphothiamineThioctic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Michael Brownlee, M.D.

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 24, 2008

Study Start

February 1, 2005

Primary Completion

October 1, 2006

Study Completion

February 1, 2008

Last Updated

November 12, 2019

Record last verified: 2008-06

Locations

US(1)