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

• Sponsor: Umeå University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01513798
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Modified paleolithic diet and exercise under observation; Behavioral: Modified paleolithic diet and general advice on exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise under observation Modified paleolithic diet and exercise 3 sessions/week under observation	Behavioral: Modified paleolithic diet and exercise under observation; Modified paleolithic diet and exercise 3 session/week under observation
Experimental: General advice on exercise Modified paleolithic diet and general advice on exercise	Behavioral: Modified paleolithic diet and general advice on exercise; Modified paleolithic diet and general advice on exercise

Outcome Measures

Primary Outcome Measures

1. Fat mass [Baseline - 12 weeks]

   Measured with DEXA (dual energy x-ray absorptiometry)

Secondary Outcome Measures

1. Peripheral insulin sensitivity [Baseline - 12 weeks]

   Measured with euglycemic hyperinsulinemic clamp

2. Hepatic insulin sensitivity [Baseline - 12 weeks]

   Measured with euglycemic hyperinsulinemic clamp

3. Liver fat [Baseline - 12 weeks]

   Measured with 1H-MRS (proton magnetic resonance spectroscopy)

4. Cortisol turnover [Baseline - 12 weeks]

5. Appetite regulation [Baseline - 12 weeks]

   GLP-1 (glucagon-like peptide 1), peptide YY

6. Dopamine 2-receptors in striatum [Baseline - 12 weeks]

   PET

7. Executive ability and memory [Baseline - 12 weeks]

   fMRI (functional magnetic resonance imaging)

8. 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)

9. Validity of energy intake and protein intake [Baseline - 6 weeks - 12 weeks]

   Actiheart®, food diary, weight, nitrogen excretion

10. Oxygen Uptake [Baseline - 12 weeks]

    Cardiopulmonary exercise testing

11. Anaerobic Threshold [Baseline - 12 weeks]

    Cardiopulmonary exercise testing

12. Substrate utilization during submaximal exercise [Baseline - 12 weeks]

    Measured with indirect calorimetry during ergometer cycling

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Public Health and Clinical Medicine, Medicine	Umeå		Sweden	90187

Sponsors and Collaborators

• Umeå University

Investigators

• Principal Investigator: Tommy Olsson, Professor, Department of Public Health and Clinical Medicine, Umeå University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tommy Olsson, Professor, Umeå University
• ClinicalTrials.gov Identifier: NCT01513798
• Other Study ID Numbers: Dnr 2011-294-31M
• First Posted: Jan 20, 2012
• Last Update Posted: Feb 26, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Tommy Olsson, Professor, Umeå University: Diet Therapy; Exercise Therapy; Insulin Resistance
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 26, 2015