Brain-derived Neurotrophic Factor and Cogntive Function

Cognitive Dysfunction Clinical Trial

Official title:

Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01390688
• Other study ID #: H-4-2011-031
• Status: Active, not recruiting
• Phase: N/A
• First received: July 5, 2011
• Last updated: July 7, 2011
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction followed by dementia in late life. Obesity, physical inactivity and "systemic low-grade inflammation" are strong risk factors and play a crucial role in this network of diseases.

Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity and type 2 diabetes.

The investigators include 200 individuals divided into three groups: 80 individuals with type 2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose tolerance.

The project will test the hypothesis, that low systemic BDNF are associated with accumulation of abdominal fat, cognitive dysfunction and insulin resistence with different effect in men and women.

Description:

Methods:

200 individuals in age 40-65 years are recruited and categorized into 3 groups: 1. Type 2 Diabetes, 2. Impaired glucose Tolerance and 3. Normal Glucose Tolerance. Groups are supposed to be age and BMI-matched.

Measurements of systemic BDNF, cogntive function (memory, attention and langue), fitness, bodycomposition, glucose metabolism and systemic inflammation are done.

Multiple regression analysis are perfomed to explain variablity in cognitive function, with age, visceral fat and BDNF as explanotory varibales.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 40-65 years of age

Exclusion Criteria:

• Chronic inflammatory diseases or infectious diseaases within 3 month prior to visit

• Fasting glucose > 12 mmol/l

• Hypertension: systolic >180 mmHg and Diastolic >110 mmHg

• Intake of more than 2 oral antidiabetic drugs or any TZD drung within 3 months before recruitment

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bodycomposition
• Cognition Disorders
• Cognitive Dysfunction
• Glucose Metabolism
• Inflammation
• Low-grade Inflammation

Locations

Country	Name	City	State
Denmark	Centre of Inflammation and Metabolism	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic Brain derived neurotrophic factor	Circulating Brain derived neurotropic factor will be analyzed in plasma and serum in middelaged volunteers. Levels will be related to on one hand metabolic parameteres such as insulin sensitivity and glucose tolerance and on the other hand to cognitive functions measured by a cognitive test battery.	Baseline	No
Secondary	Cognitive function and bodycompisition	Results from cogntive measurements will by multiple regression analysis be related to bodycomposition (Intraabdominal fat, total bodyfat, waist) and fitness (single stage max-test).	Baseline	No