Alzheimer DiseaseNCT03038282
Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients
A study testing Chromium Chloride and Individual Exercise in people with Alzheimer Disease, run by Metabolic Therapy Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Chromium Chloride and Individual Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2017to 20 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Dewey C Brown II, PhD contact
About this study
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.
Read the detailed description
Chromium is an essential nutrient required for optimal insulin activity and normal carbohydrate and lipid metabolism. Beyond its nutritional effects, dietary supplement of chromium causes beneficial outcomes against several diseases, in particular diabetes-associated complications such as Alzheimer Disease. Common forms include chromium chloride, chromium nicotinate, and chromium picolinate.
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
- Alzheimer Disease
- Being tested
- Chromium Chloride, Individual Exercise
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromium ChlorideDietary supplement
Transdermal chromium chloride 50 to 600 mcg/day.
Individual ExerciseOther
Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chromium Chloride | Experimental | Participants transdermal chromium chloride 50 to 600 mcg/day. Receives: Dietary Supplement: Chromium Chloride |
| Individual Exercise | Experimental | Exercise 150 minutes per week (over 3 to 5 days) for 12 weeks. Receives: Other: Individual Exercise |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
Measured: Change from Baseline to 12 weeks
Secondary outcomes (1)
Change in chronic refractory mood disorders
To be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests.
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start20 Feb 2017 (estimated)
- Primary completion20 Aug 2019 (estimated)
- Study completion20 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metabolic Therapy Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreana Haley, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038282
- Sponsor's protocol ID
- 1R01TCR012617
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing data will be available upon written request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients
- ClinicalTrials.gov ID
- NCT03038282
- Acronym / sponsor ID
- 1R01TCR012617
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Metabolic Therapy Inc.University, hospital or other
- Study start
- 20 Feb 2017 (estimated)
- Primary completion
- 20 Aug 2019 (estimated)
- Study completion
- 20 Oct 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chromium is an essential nutrient required for optimal insulin activity and normal carbohydrate and lipid metabolism. Beyond its nutritional effects, dietary supplement of chromium causes beneficial outcomes against several diseases, in particular diabetes-associated complications such as Alzheimer Disease. Common forms include chromium chloride, chromium nicotinate, and chromium picolinate.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chromium Chloride | Experimental | Dietary Supplement: Chromium ChlorideParticipants transdermal chromium chloride 50 to 600 mcg/day. |
| Individual Exercise | Experimental | Other: Individual ExerciseExercise 150 minutes per week (over 3 to 5 days) for 12 weeks. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromium ChlorideTransdermal chromium chloride 50 to 600 mcg/day. | Dietary supplement | Chromium Chloride |
| Individual ExerciseParticipants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks | Other | Individual Exercise |
Primary outcome
Insulin Resistance
Time frame: Change from Baseline to 12 weeks
Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
1 secondary outcome
Change in chronic refractory mood disorders
Time frame: Change from Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided. Sharing data will be available upon written request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dewey C Brown II, PhD contact
Andreana Haley, PhD principal investigator
University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing Chromium Chloride and Individual Exercise in people with Alzheimer Disease, run by Metabolic Therapy Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dewey C Brown II, PhD (2145174004), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (time frame: Change from Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.