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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT01513798
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-25
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fat mass	Baseline - 12 weeks	Measured with DEXA (dual energy x-ray absorptiometry)

Secondary Outcome Measures

Name	Time	Method
Hepatic insulin sensitivity	Baseline - 12 weeks	Measured with euglycemic hyperinsulinemic clamp
Appetite regulation	Baseline - 12 weeks	GLP-1 (glucagon-like peptide 1), peptide YY
Dopamine 2-receptors in striatum	Baseline - 12 weeks	PET
Anaerobic Threshold	Baseline - 12 weeks	Cardiopulmonary exercise testing
Substrate utilization during submaximal exercise	Baseline - 12 weeks	Measured with indirect calorimetry during ergometer cycling
Liver fat	Baseline - 12 weeks	Measured with 1H-MRS (proton magnetic resonance spectroscopy)
Cortisol turnover	Baseline - 12 weeks
Executive ability and memory	Baseline - 12 weeks	fMRI (functional magnetic resonance imaging)
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
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)

Trial Locations

Locations (1)

Department of Public Health and Clinical Medicine, Medicine; 🇸🇪 Umeå, Sweden