Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients

Not Applicable

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: Chromium Chloride; Other: Individual Exercise

• Registration Number: NCT03038282
• Lead Sponsor: Metabolic Therapy Inc.

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.

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 Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-27
• Last Update Submitted: 2017-01-27
• Study First Posted: 2017-01-31
• Last Update Posted: 2017-01-31
• Study Start: 2017-02-20
• Primary Completion: 2019-08-20
• Study Completion: 2019-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chromium Chloride	Chromium Chloride	Participants transdermal chromium chloride 50 to 600 mcg/day.
Individual Exercise	Individual Exercise	Exercise 150 minutes per week (over 3 to 5 days) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Insulin Resistance	Change from Baseline to 12 weeks	Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Change in chronic refractory mood disorders	Change from Baseline to 12 weeks	To be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests.