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Clinical Trials/NCT01390688
NCT01390688
Unknown
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country200 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Dysfunction
Sponsor
Rigshospitalet, Denmark
Enrollment
200
Locations
1
Primary Endpoint
Systemic Brain derived neurotrophic factor
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
March 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Systemic Brain derived neurotrophic factor

Time Frame: 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 Outcomes

  • Cognitive function and bodycompisition(Baseline)

Study Sites (1)

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