Alzheimer's Disease Biomarkers in Cerebrospinal Fluid in Insulin-resistant Men

NCT02010476 | Completed

• 1 other identifier: 3971
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus has been associated with an about 2-fold increase in risk of Alzheimer's disease (AD). Patients with AD have been reported to have reduced insulin sensitivity. It may be hypothesized that, compared to insulin sensitive subjects otherwise similar in general health and body habitus, insulin resistant subjects are more likely to have cerebrospinal fluid (CSF) indicators of incipient AD pathology, abnormalities in CSF peptides related to insulin signaling and glucose homeostasis, and possibly other metabolites that are associated with a risk of AD. The objective of this study is to examine the relation of insulin resistance and the concentrations of CSF biomarkers. The results of this study may be useful in the detection of the subjects who are at risk for cognitive decline and AD.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, CSF biomarkers, Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Abnormal concentrations of CSF biomarkers related to Alzheimer's disease

  during a single visit, i.e., day 1

Secondary Outcomes (1)

• Abnormal concentrations of other CSF biomarkers of potential relevance to insulin resistance and Alzheimer's disease

  during a single visit, i.e., day 1

Study Arms (2)

Normal insulin sensitivity

cognitively normal men without insulin resistance

Insulin resistance

cognitively normal men with insulin resistance

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the research data sources of METSIM study (METabolic Syndrome In Men; professor Markku Laakso) performed in the Department of Internal Medicine, University of Eastern Finland

You may qualify if:

• Males 55-70 years in age
• Normal cognitive function, as evidenced by the following: 1. Living independently in the community, 2. No memory complaints; Score on Mini Mental State Examination \>= 25 (Folstein 1975), 3. Score on Functional Activities Questionnaire \< 9
• Has had oral glucose tolerance test including determination of plasma glucose and insulin levels at baseline and 30 and 120 minutes within the past 3 months, meeting the following criteria: 1. Normal fasting blood glucose (\<7.0 mmol/l), 2. Normal glucose tolerance at 120 minutes (\<11.1 mmol/l), 3. Meets criteria for either normal insulin sensitivity or insulin resistance, based upon the Matsuda insulin sensitivity index
• Willing to have lumbar puncture

You may not qualify if:

• Evidence of significant neurological disease, including 1. Abnormal neurological examination, 2. History of stroke (other than lacunar infarction), 3. prior diagnosis of mild cognitive impairment, significant head injury with impairment of consciousness \> 24h, brain tumor, multiple sclerosis, epilepsy, or hydrocephalus, 4. Diagnosis or family history consistent with autosomal dominantly inherited AD
• Prior diagnosis of diabetes mellitus type 1 or 2
• Evidence of significant metabolic or endocrine disorder associated with risk of cognitive impairment, e.g., hypothyroidism or B12 deficiency
• Major psychiatric disorder, including psychosis
• Evidence of significant systemic disease, including: congestive heart failure, renal failure, hepatic cirrhosis, significant chronic obstructive pulmonary disease, cancer within the past 5 years (other than nonmetastatic basal cell and squamous cell carcinoma of the skin)
• Excluded concomitant medications: 1. Acetylcholinesterase inhibitors, Memantine (Alzheimer's disease medications), 2. Insulin or oral hypoglycemics, 3. Anticoagulants (excluding aspirin, clopidogrel, dipyridamole, or other antiplatelet drugs), 4. Neuroleptic drugs, including risperidone, olanzapine, quetiapine, and ziprasidone, 5. Receipt of an investigational drug within the past 30 days (or within 5 half-lives of an investigational drug, whatever is longest)

Sponsors & Collaborators

• University of Eastern Finland: lead
• King's College London: collaborator
• Sahlgrenska University Hospital: collaborator
• Janssen Pharmaceutica: collaborator

Study Sites (1)

Department of Neurology and Brain Research Unit, Institute of Clinical Medicine, University of Eastern Finland

Kuopio, FI-70211, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, white cells, urine, cerebrospinal fluid

MeSH Terms

Conditions

Alzheimer Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hilkka Soininen, Professor

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

FI (1)