Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients
NCT ID: NCT03038282
Last Updated: 2017-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-02-20
2019-10-20
Brief Summary
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Detailed Description
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The argument for chromium supplementation relies on evidence from case reports of resolution of diabetic symptoms refractory to insulin via chromium added to total parenteral nutrition, and experiments in which animals deficient in chromium exhibited impaired glucose metabolism.
Chromium may influence glucose metabolism by increasing the number of insulin receptors or by binding insulin to receptors. The US Food and Drug Administration concludes that, based on recent studies, chromium picolinate may reduce the risk of insulin resistance and therefore may reduce the risk of type 2 diabetes.
A number of systematic reviews and meta-analyses have been conducted to determine the effect of chromium on glycemic control, although large, quality trials are limited. The majority of studies have found no effect on measured outcomes, with a few studies contributing to the positive observed effects. Variations of preparations used in the trials and study conditions make generalization of the results difficult.
In order to provide a comprehensive clinical evaluation of the effects of Chromium in AD patients, we will conduct a double-blinded and placebo-controlled trial in subjects with AD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chromium Chloride
Participants transdermal chromium chloride 50 to 600 mcg/day.
Chromium Chloride
Transdermal chromium chloride 50 to 600 mcg/day.
Individual Exercise
Exercise 150 minutes per week (over 3 to 5 days) for 12 weeks.
Individual Exercise
Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
Control Group
Participants or participant's caregiver will be provided educational materials on starting an exercise program and instructions for the application of transdermal chromium chloride, but will receive no formal support for their exercise program.
No interventions assigned to this group
Interventions
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Chromium Chloride
Transdermal chromium chloride 50 to 600 mcg/day.
Individual Exercise
Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Exhibiting an onset and progression of cognitive dysfunction during at least 3 months prior to the screening period.
Exclusion Criteria
* Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc.
* Patients with clinically significant cardiovascular disease.
* Patients with history of clinically-evident stroke.
* Patients with history of cancer in the last 5 years.
* Patients with clinically-significant systemic illness that may affect safety or completion of the study.
65 Years
ALL
No
Sponsors
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Metabolic Therapy Inc.
OTHER
Responsible Party
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Principal Investigators
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Andreana Haley, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas - Austin
Central Contacts
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Dewey C Brown II, PhD
Role: CONTACT
Phone: 2145174004
Other Identifiers
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1R01TCR012617
Identifier Type: -
Identifier Source: org_study_id