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

Umeå University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Modified paleolithic diet and general advice on exercise; Behavioral: Modified paleolithic diet and exercise under observation

Study type: Interventional

Funder types: Other

Identifiers

NCT01513798

Dnr 2011-294-31M

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Exercise under observation

Experimental group

Description:

Modified paleolithic diet and exercise 3 sessions/week under observation

Treatment:

Behavioral: Modified paleolithic diet and exercise under observation

General advice on exercise

Experimental group

Description:

Modified paleolithic diet and general advice on exercise

Treatment:

Behavioral: Modified paleolithic diet and general advice on exercise