Diabetes Mellitus, Type 2
Conditions
Keywords
Diet Therapy, Exercise Therapy, Insulin Resistance
Brief summary
The investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. The investigators randomize 40 participants to two groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2) Modified paleolithic diet and general advice about exercise. The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet.
Interventions
BEHAVIORALModified paleolithic diet and exercise under observation
Modified paleolithic diet and exercise 3 session/week under observation
BEHAVIORALModified paleolithic diet and general advice on exercise
Modified paleolithic diet and general advice on exercise
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes less than 10 years * BMI 27-35 * women only after menopause * diabetes treatment with diet and/or metformin * HbA1c between 45 and 94
Exclusion criteria
* nicotine use * insulin * betablockers * estrogens orally * blod pressure \>160/100 * macroalbuminuria * malignancy during the past 5 years * alcoholism * depression * cardiovascular disease/stroke * liver disease * serious lung disease, GI disease or kidney disease * more than 30 minutes/5 days a week of moderate exercise during the last 6 months * resistance training during the past 6 months * official weight loosing program during the past year * obesity surgery * night work * MADRS-S (Montgomery Asberg Depression Rating Scale) \>20 points * AUDIT \>14 points for women, \>16 points for men * not possible to obtain venous sampling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | Baseline - 12 weeks | Measured with DEXA (dual energy x-ray absorptiometry) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic insulin sensitivity | Baseline - 12 weeks | Measured with euglycemic hyperinsulinemic clamp |
| Liver fat | Baseline - 12 weeks | Measured with 1H-MRS (proton magnetic resonance spectroscopy) |
| Cortisol turnover | Baseline - 12 weeks | — |
| Appetite regulation | Baseline - 12 weeks | GLP-1 (glucagon-like peptide 1), peptide YY |
| Dopamine 2-receptors in striatum | Baseline - 12 weeks | PET |
| Peripheral insulin sensitivity | Baseline - 12 weeks | Measured with euglycemic hyperinsulinemic clamp |
| Experience of training | Baseline - 12 weeks | SCI ESES (Spinal Cord Injury Exercise Self-Efficacy Scale, ABC (Activities-specific Balance Confidence scale), PRETIE-Q (Preference for and Tolerance of the Intensity of Exercise Questionnaire) |
| Validity of energy intake and protein intake | Baseline - 6 weeks - 12 weeks | Actiheart®, food diary, weight, nitrogen excretion |
| Oxygen Uptake | Baseline - 12 weeks | Cardiopulmonary exercise testing |
| Anaerobic Threshold | Baseline - 12 weeks | Cardiopulmonary exercise testing |
| Substrate utilization during submaximal exercise | Baseline - 12 weeks | Measured with indirect calorimetry during ergometer cycling |
| Executive ability and memory | Baseline - 12 weeks | fMRI (functional magnetic resonance imaging) |
Countries
Sweden
Outcome results
None listed