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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Modified paleolithic diet and exercise under observation; Behavioral: Modified paleolithic diet and general advice on exercise

• 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

Arm && Interventions

Group	Intervention	Description
Exercise under observation	Modified paleolithic diet and exercise under observation	Modified paleolithic diet and exercise 3 sessions/week under observation
General advice on exercise	Modified paleolithic diet and general advice on exercise	Modified paleolithic diet and general advice on exercise

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