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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513798
• Other study ID #: Dnr 2011-294-31M
• Status: Completed
• Phase: N/A
• First received: January 16, 2012
• Last updated: February 25, 2015
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Modified paleolithic diet and exercise under observation
Modified paleolithic diet and exercise 3 session/week under observation
• Modified paleolithic diet and general advice on exercise
Modified paleolithic diet and general advice on exercise

Locations

Country	Name	City	State
Sweden	Department of Public Health and Clinical Medicine, Medicine	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass	Measured with DEXA (dual energy x-ray absorptiometry)	Baseline - 12 weeks	No
Secondary	Peripheral insulin sensitivity	Measured with euglycemic hyperinsulinemic clamp	Baseline - 12 weeks	No
Secondary	Hepatic insulin sensitivity	Measured with euglycemic hyperinsulinemic clamp	Baseline - 12 weeks	No
Secondary	Liver fat	Measured with 1H-MRS (proton magnetic resonance spectroscopy)	Baseline - 12 weeks	No
Secondary	Cortisol turnover		Baseline - 12 weeks	No
Secondary	Appetite regulation	GLP-1 (glucagon-like peptide 1), peptide YY	Baseline - 12 weeks	No
Secondary	Dopamine 2-receptors in striatum	PET	Baseline - 12 weeks	No
Secondary	Executive ability and memory	fMRI (functional magnetic resonance imaging)	Baseline - 12 weeks	No
Secondary	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	No
Secondary	Validity of energy intake and protein intake	Actiheart®, food diary, weight, nitrogen excretion	Baseline - 6 weeks - 12 weeks	No
Secondary	Oxygen Uptake	Cardiopulmonary exercise testing	Baseline - 12 weeks	No
Secondary	Anaerobic Threshold	Cardiopulmonary exercise testing	Baseline - 12 weeks	No
Secondary	Substrate utilization during submaximal exercise	Measured with indirect calorimetry during ergometer cycling	Baseline - 12 weeks	No