Brain-derived Neurotrophic Factor and Cogntive Function

• Conditions: Low-grade Inflammation; Cognitive Dysfunction; Bodycomposition; Glucose Metabolism

• Registration Number: NCT01390688
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Primary Completion: 2010-12
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-07
• Last Update Submitted: 2011-07-07
• Study First Posted: 2011-07-11
• Last Update Posted: 2011-07-11
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systemic Brain derived neurotrophic factor	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive function and bodycompisition	Baseline	Results from cogntive measurements will by multiple regression analysis be related to bodycomposition (Intraabdominal fat, total bodyfat, waist) and fitness (single stage max-test).

Trial Locations

Locations (1)

Centre of Inflammation and Metabolism; 🇩🇰 Copenhagen, Denmark