Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Modified paleolithic diet and exercise under observation
* Behavioral: Modified paleolithic diet and general advice on exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise under observation<br>Modified paleolithic diet and exercise 3 sessions/week under observation | Behavioral: Modified paleolithic diet and exercise under observation<br>* Modified paleolithic diet and exercise 3 session/week under observation<br>|
| Experimental: General advice on exercise<br>Modified paleolithic diet and general advice on exercise | Behavioral: Modified paleolithic diet and general advice on exercise<br>* Modified paleolithic diet and general advice on exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass | Measured with DEXA (dual energy x-ray absorptiometry) | Baseline - 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral insulin sensitivity | Measured with euglycemic hyperinsulinemic clamp | Baseline - 12 weeks | 
| Hepatic insulin sensitivity | Measured with euglycemic hyperinsulinemic clamp | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet Therapy, Exercise Therapy, Insulin Resistance