Overview

This trial is active, not recruiting.

Conditions cognitive dysfunction, glucose metabolism, low-grade inflammation, bodycomposition
Sponsor Rigshospitalet, Denmark
Start date June 2009
End date December 2010
Trial size 200 participants
Trial identifier NCT01390688, H-4-2011-031

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
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
40 individuals with impaired glucose tolerance. age 40 -65 years, BMI > 18. 5 kg/m2
80 Individuals without type 2 diabetes Age 40-65 years, BMI >18.5 kg/m2.

Primary Outcomes

Measure
Systemic Brain derived neurotrophic factor
time frame: Baseline

Secondary Outcomes

Measure
Cognitive function and bodycompisition
time frame: Baseline

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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

Additional Information

Official title Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.