- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01390688
Brain-derived Neurotrophic Factor and Cogntive Function
Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?
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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Copenhagen, Danmark, 2100
- Centre of Inflammation and Metabolism
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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
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Impaired glucose tolerance
40 individuals with impaired glucose tolerance.
age 40 -65 years, BMI > 18. 5 kg/m2
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Normal glucose tolerance
80 Individuals without type 2 diabetes Age 40-65 years, BMI >18.5 kg/m2.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Systemic Brain derived neurotrophic factor
Tidsramme: Baseline
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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.
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Baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cognitive function and bodycompisition
Tidsramme: Baseline
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Results from cogntive measurements will by multiple regression analysis be related to bodycomposition (Intraabdominal fat, total bodyfat, waist) and fitness (single stage max-test).
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Baseline
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-4-2011-031
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