Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Dietary supplement: Chromium Chloride; Other: Individual Exercise

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chromium Chloride; Participants transdermal chromium chloride 50 to 600 mcg/day.	Dietary supplement: Chromium Chloride; Transdermal chromium chloride 50 to 600 mcg/day.
Experimental: Individual Exercise; Exercise 150 minutes per week (over 3 to 5 days) for 12 weeks.	Other: Individual Exercise; Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Metabolic Therapy Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2017
• Primary Completion (Anticipated): August 20, 2019
• Study Completion (Anticipated): October 20, 2019

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Hyperinsulinism; Dementia; Tauopathies; Alzheimer Disease; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Chromium; Chromous chloride
• Other Study ID Numbers: 1R01TCR012617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Sharing data will be available upon written request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No