Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in vivo, ex vivo and in vitro
- Conditions
- endurance athletes, obesity, lean sedentarydiabetestype 2 diabetes mellitus1001842410013317
- Registration Number
- NL-OMON38384
- Lead Sponsor
- Human Biology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 132
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 < 8%
- No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
- No other (genetic) diseases that are associated with altered lipid profiles (including familial hypercholesterolemia and familiar combined hyperlipemia);Group 2, obese healthy control participants:
- Ages 40-70 years
- BMI > 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 < 25 kg/m2
- No family history of diabetes
- No medication use
- VO2max > 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 < 25 kg/m2
- No family history of diabetes
- No medication use
- VO2max < 55ml/kg/min
- Plasma glucose < 6.1 mmol/L
- Sedentary lifestyle; No participation in physical activity for more than 1 hour per week for at least 2 years
- No dyslipidemia (including familial hypercholesterolemia and familiar combined hyperlipemia)
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 < 7.8 in type 2 diabetic individuals
- Contraindications for MRS scans:
• Electronic implants such as pacemakers or neurostimulator
• Iron-containing foreign bodies in eyes or brain
• Some hearing aids and artificial (heart) valves which are contraindicated for MRS
• Claustrophobia
- Participants, who do not want to be informed about unexpected medical findings, or do not wish that their physician is informed, cannot participate in the study.
- Participants who have been involved in studies (or for medical reasons) with medical radiation (PET-CT scans)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The Primary Objective is to assess metabolic flexibility in vivo in a broad<br /><br>spectrum of individuals from highly insulin sensitive athletes to those with<br /><br>overt type 2 diabetes (T2D) and their control counterparts. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The Secondary Objectives are to assess mitochondrial function in vivo and ex<br /><br>vivo and quantify lipid content and acetylcarnitine concentrations in skeletal<br /><br>muscle of endurance athletes, type 2 diabetes patients and sedentary lean and<br /><br>obese controls. Furthermore, brown adipose tissue activity (Standard Uptake<br /><br>Values (SUV)) and brown adipocyte recruitment in WAT will be measured in the<br /><br>endurance athletes and lean sedentary subjects. UCP-1 and beta-receptor<br /><br>polymorphisms.<br /><br><br /><br>The Tertiary Objective is to establish primary myoblast cell lines from<br /><br>endurance athlete, sedentary lean and obese, and type 2 diabetic donors to<br /><br>further characterize muscle function via dietary, pharmacological and genetic<br /><br>manipulations in vitro.</p><br>