Brain-derived Neurotrophic Factor and Cogntive Function

NCT01390688 | Unknown DMC

• 1 other identifier: H-4-2011-031
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Glucose Metabolism; Low-grade Inflammation; Bodycomposition

Keywords

Brain-derived Neurotrophic factor; Low-grade inflammation; Cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• Systemic Brain derived neurotrophic factor

  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.

  Baseline

Secondary Outcomes (1)

• Cognitive function and bodycompisition

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from newspapers.

You may qualify if:

• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Centre of Inflammation and Metabolism

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, DNA, Muscle tissue and fat tissue

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 11, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2012
• Last Updated: July 11, 2011

Record last verified: 2009-06

Locations

DK (1)