Clinical trial NCT03038282: Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients
Official title: Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Metabolic Therapy Inc.
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin Resistance
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: Change in chronic refractory mood disorders
timeFrame: Change from Baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas - Austin
name: Andreana Haley, PhD
role: PRINCIPAL_INVESTIGATOR
References: