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Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in vivo, ex vivo and in vitro

Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in vivo, ex vivo and in vitro - Metabolic Phenotyping

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38384
Enrollment
132
Registered
2011-04-04
Start date
2011-07-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endurance athletes, obesity, lean sedentary diabetes type 2 diabetes mellitus

Interventions

None listed

Sponsors

Human Biology
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria: - Male sex - Generally healthy with specifically no known cardiovascular disease or gastric ulcers, which can affect the study parameters - Stable dietary habits (no weight loss/gain > 3 kg in the last 6 months);Group 1, type 2 diabetes participants: - Ages 40-70 years - BMI > 30 kg/m2 - Non-insulin dependent type 2 diabetes - Must be on sulphonylurea(SU)- derivate or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months - Well-controlled diabetes: HbA1c 30 kg/m2 - A plasma glucose level lower than 6.1 mmol/L - No family history of diabetes - No medication use - Sedentary lifestyle; No participation in any physical activity for at least 2 years - No other (genetic) diseases that are associated with altered lipid profiles (including familial hypercholesterolemia and familiar combined hyperlipemia);Group 3, endurance trained athletes: - Ages 18-35 years - BMI 55ml/kg/min - Active in competitive endurance-exercise activities, 3 times a week for at least 2 years - Stable level of training for at least 6 months - No dyslipidemia (including familial hypercholesterolemia and familiar combined hyperlipemia);Group 4, lean healthy sedentary control participants: - Ages 18-35 years - BMI

Exclusion criteria

Exclusion criteria: General exclusion criteria: - Regular smokers - Participation in other studies - Female sex - Insulin dependent diabetic individuals - Participants with diabetes related diseases (diabetic foot, diabetic polyneuropathy, diabetic retinopathy etc.) - Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone) - Use of anti-coagulants (not trombocyte-aggregation inhibitors) - Aberrant ECG (with signs of ischemia or cardiac failure or arrythmias) - Weight gain/loss > 3 kg in the last 6 months - HbA1c

Design outcomes

Primary

MeasureTime frame
The Primary Objective is to assess metabolic flexibility in vivo in a broad spectrum of individuals from highly insulin sensitive athletes to those with overt type 2 diabetes (T2D) and their control counterparts.

Secondary

MeasureTime frame
The Secondary Objectives are to assess mitochondrial function in vivo and ex vivo and quantify lipid content and acetylcarnitine concentrations in skeletal muscle of endurance athletes, type 2 diabetes patients and sedentary lean and obese controls. Furthermore, brown adipose tissue activity (Standard Uptake Values (SUV)) and brown adipocyte recruitment in WAT will be measured in the endurance athletes and lean sedentary subjects. UCP-1 and beta-receptor polymorphisms. The Tertiary Objective is to establish primary myoblast cell lines from endurance athlete, sedentary lean and obese, and type 2 diabetic donors to further characterize muscle function via dietary, pharmacological and genetic manipulations in vitro.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)