Brain-derived Neurotrophic Factor and Cogntive Function

NCT ID: NCT01390688

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Cognitive Dysfunction Glucose Metabolism Low-grade Inflammation Bodycomposition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

Impaired glucose tolerance

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

No interventions assigned to this group

Normal glucose tolerance

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Centre of Inflammation and Metabolism

Locations

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Centre of Inflammation and Metabolism

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-4-2011-031

Identifier Type: -

Identifier Source: org_study_id

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