adult-onset diabetes type 2 diabetes mellitus
Conditions
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male subjects between the age of 30-70 years have to be overweight or obese (BMI >7.8 * 11.1 mmol/L and/or fasting glucose 5.6 - 6.9 mmol/L). In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight:
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation when one or more of the following aspects are present: cardiovascular disease (determined by questionnaire, blood pressure (Subjects with moderate to severe hypertension (grade 2 or 3 based on WHO criteria) will be excluded from participation in this study (SBP > 160 mmHg, DBP > 100 mmHg)) and an electrocardiogram (ECG)), type 2 diabetes mellitus, cancer, asthma, bronchitis, chronic obstructive pulmonary disease (COPD), lung fibrosis, obstructive sleep apnea (OSAS), use of oxygen at home situation, resting SpO2 *93%, abnormal pre-bronchodilator forced expiratory volume (FEV1) and forced vital capacity (FVC) (based on spirometry), liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively), disease with a life expectancy shorter then 5 years (subjects will be asked if they have a disease, which could lead to death within 5 years, the life expectancy will be estimated by the investigator) diagnosis, lactose intolerance, abuse of products (alcohol consumption > 15 units/week), smoking, plans to lose weight (subjects will be asked if they have weight loss plans (e.g. to increase their physical activity level or change diet): a positive answer will lead to exclusion) or follow a hypocaloric diet, participation in organized sports activities more than three hours a week, use of high doses of anti-oxidant vitamins (A, C, E, *-carotene; a standard multi-vitamin capsule is permitted if less than 800*g/day Vit A, 60mg/day Vit C, 10mg/day Vit E and 400*g/day *-carotene) or use of any medication that influences glucose metabolism and inflammation. Furthermore, shift-workers will be excluded from participation as well.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average 24h glucose concentration (at day 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic variability over 24 hours Time in hyper/hypoglycaemia Energy expenditure Substrate oxidation Fasting and postprandial plasma metabolites Systemic inflammatory markers Blood pressure HOMA-IR Gene/Protein expression (i.e. metabolic/inflammatory parameters) in skeletal muscle tissue | — |
Countries
Netherlands
Outcome results
None listed