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Brain-derived Neurotrophic Factor and Cogntive Function

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT01390688
Collaborator
(none)
200
Enrollment
1
Location
33
Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2010
    Anticipated Study Completion Date :
    Mar 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Type 2 Diabetes

    80 individuals with type 2 Diabetes, confirmed by an OGTT, age 40-65 years, BMI > 18.5 kg/m2 fatsing plasma glucose < 12 mmol/l
    Impaired glucose tolerance

    40 individuals with impaired glucose tolerance. age 40 -65 years, BMI > 18. 5 kg/m2
    Normal glucose tolerance

    80 Individuals without type 2 diabetes Age 40-65 years, BMI >18.5 kg/m2.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre of Inflammation and Metabolism Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01390688
    Other Study ID Numbers:
    • H-4-2011-031
    First Posted:
    Jul 11, 2011
    Last Update Posted:
    Jul 11, 2011
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Brain-derived Neurotrophic factor
    Low-grade inflammation
    Cognitive dysfunction
    Additional relevant MeSH terms:
    Inflammation
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Jul 11, 2011