Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
The effect of Chromium to improve glucose levels in Alzheimer Disease (AD) is controversial. The hypothesis of the study is to evaluate the effect of supplementing the AD individuals with Chromium combined with exercise and assessing the effect of the supplementation on glucose metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Feb 2017
Typical duration for not_applicable alzheimer-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
February 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2019
CompletedJanuary 31, 2017
January 1, 2017
2.5 years
January 26, 2017
January 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Insulin Resistance
Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
Change from Baseline to 12 weeks
Secondary Outcomes (1)
Change in chronic refractory mood disorders
Change from Baseline to 12 weeks
Study Arms (3)
Chromium Chloride
EXPERIMENTALParticipants transdermal chromium chloride 50 to 600 mcg/day.
Individual Exercise
EXPERIMENTALExercise 150 minutes per week (over 3 to 5 days) for 12 weeks.
Control Group
NO INTERVENTIONParticipants 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.
Interventions
Transdermal chromium chloride 50 to 600 mcg/day.
Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
Eligibility Criteria
You may qualify if:
- Outpatients with a diagnosis of Alzheimer's disease.
- Exhibiting an onset and progression of cognitive dysfunction during at least 3 months prior to the screening period.
You may not qualify if:
- Patients with neurodegenerative diseases other than Alzheimer's disease.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreana Haley, PhD
University of Texas at Austin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants, Investigator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2017
First Posted
January 31, 2017
Study Start
February 20, 2017
Primary Completion
August 20, 2019
Study Completion
October 20, 2019
Last Updated
January 31, 2017
Record last verified: 2017-01