Brain-derived Neurotrophic Factor and Cogntive Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01390688
First received: July 5, 2011
Last updated: July 7, 2011
Last verified: June 2009

July 5, 2011
July 7, 2011
June 2009
December 2010   (final data collection date for primary outcome measure)
Systemic Brain derived neurotrophic factor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01390688 on ClinicalTrials.gov Archive Site
Cognitive function and bodycompisition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Results from cogntive measurements will by multiple regression analysis be related to bodycomposition (Intraabdominal fat, total bodyfat, waist) and fitness (single stage max-test).
Same as current
Not Provided
Not Provided
 
Brain-derived Neurotrophic Factor and Cogntive Function
Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Plasma, Serum, DNA, Muscle tissue and fat tissue

Non-Probability Sample

Participants will be selected from newspapers.

  • Cognitive Dysfunction
  • Glucose Metabolism
  • Low-grade Inflammation
  • Bodycomposition
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
March 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01390688
H-4-2011-031
Yes
Maria Pedersen/ MD, Centre of Inflammation and Metabolism
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP