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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise under observation | Experimental | Modified paleolithic diet and exercise 3 sessions/week under observation |
|
| General advice on exercise | Experimental | Modified paleolithic diet and general advice on exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified paleolithic diet and exercise under observation | Behavioral | Modified paleolithic diet and exercise 3 session/week under observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass | Measured with DEXA (dual energy x-ray absorptiometry) | Baseline - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral insulin sensitivity | Measured with euglycemic hyperinsulinemic clamp | Baseline - 12 weeks |
| Hepatic insulin sensitivity | Measured with euglycemic hyperinsulinemic clamp |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tommy Olsson, Professor | Department of Public Health and Clinical Medicine, Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Public Health and Clinical Medicine, Medicine | Umeå | 90187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30652528 | Derived | Otten J, Andersson J, Stahl J, Stomby A, Saleh A, Waling M, Ryberg M, Hauksson J, Svensson M, Johansson B, Olsson T. Exercise Training Adds Cardiometabolic Benefits of a Paleolithic Diet in Type 2 Diabetes Mellitus. J Am Heart Assoc. 2019 Jan 22;8(2):e010634. doi: 10.1161/JAHA.118.010634. | |
| 29696296 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Modified paleolithic diet and general advice on exercise | Behavioral | Modified paleolithic diet and general advice on exercise |
|
| Baseline - 12 weeks |
| Liver fat | Measured with 1H-MRS (proton magnetic resonance spectroscopy) | Baseline - 12 weeks |
| Cortisol turnover | Baseline - 12 weeks |
| Appetite regulation | GLP-1 (glucagon-like peptide 1), peptide YY | Baseline - 12 weeks |
| Dopamine 2-receptors in striatum | PET | Baseline - 12 weeks |
| Executive ability and memory | fMRI (functional magnetic resonance imaging) | Baseline - 12 weeks |
| Experience of training | 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) | Baseline - 12 weeks |
| Validity of energy intake and protein intake | Actiheart®, food diary, weight, nitrogen excretion | Baseline - 6 weeks - 12 weeks |
| Oxygen Uptake | Cardiopulmonary exercise testing | Baseline - 12 weeks |
| Anaerobic Threshold | Cardiopulmonary exercise testing | Baseline - 12 weeks |
| Substrate utilization during submaximal exercise | Measured with indirect calorimetry during ergometer cycling | Baseline - 12 weeks |
| Otten J, Stomby A, Waling M, Isaksson A, Soderstrom I, Ryberg M, Svensson M, Hauksson J, Olsson T. A heterogeneous response of liver and skeletal muscle fat to the combination of a Paleolithic diet and exercise in obese individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2018 Jul;61(7):1548-1559. doi: 10.1007/s00125-018-4618-y. Epub 2018 Apr 26. |
| 29255413 | Derived | Stomby A, Otten J, Ryberg M, Nyberg L, Olsson T, Boraxbekk CJ. A Paleolithic Diet with and without Combined Aerobic and Resistance Exercise Increases Functional Brain Responses and Hippocampal Volume in Subjects with Type 2 Diabetes. Front Aging Neurosci. 2017 Dec 4;9:391. doi: 10.3389/fnagi.2017.00391. eCollection 2017. |
| 27235022 | Derived | Otten J, Stomby A, Waling M, Isaksson A, Tellstrom A, Lundin-Olsson L, Brage S, Ryberg M, Svensson M, Olsson T. Benefits of a Paleolithic diet with and without supervised exercise on fat mass, insulin sensitivity, and glycemic control: a randomized controlled trial in individuals with type 2 diabetes. Diabetes Metab Res Rev. 2017 Jan;33(1):10.1002/dmrr.2828. doi: 10.1002/dmrr.2828. Epub 2016 Jun 30. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |