Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients

Alzheimer Disease Clinical Trial

Official title:

Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03038282
• Other study ID #: 1R01TCR012617
• Status: Not yet recruiting
• Phase: N/A
• First received: January 26, 2017
• Last updated: January 27, 2017
• Start date: February 20, 2017
• Est. completion date: October 20, 2019

Study information

• Verified date: January 2017
• Source: Metabolic Therapy Inc.
• Contact: Dewey C Brown II, PhD
• Phone: 2145174004
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Insulin Resistance

Intervention

Dietary Supplement:
• Chromium Chloride
Transdermal chromium chloride 50 to 600 mcg/day.

Other:
• Individual Exercise
Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Metabolic Therapy Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in chronic refractory mood disorders	To be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests.	Change from Baseline to 12 weeks