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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 5, 2011
Last Updated Date	July 7, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 7, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01390688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 7, 2011)	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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Brain-derived Neurotrophic Factor and Cogntive Function
Official Title ^ICMJE	Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Plasma, Serum, DNA, Muscle tissue and fat tissue
Sampling Method	Non-Probability Sample
Study Population	Participants will be selected from newspapers.
Condition ^ICMJE	Cognitive Dysfunction Glucose Metabolism Low-grade Inflammation Bodycomposition
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	200
Estimated Completion Date	March 2012
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01390688
Other Study ID Numbers ^ICMJE	H-4-2011-031
Has Data Monitoring Committee	Yes
Responsible Party	Maria Pedersen/ MD, Centre of Inflammation and Metabolism
Study Sponsor ^ICMJE	Rigshospitalet, Denmark
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rigshospitalet, Denmark
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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