Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
NCT ID: NCT01513798
Last Updated: 2015-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-01-31
2014-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Exercise under observation
Modified paleolithic diet and exercise 3 sessions/week under observation
Modified paleolithic diet and exercise under observation
Modified paleolithic diet and exercise 3 session/week under observation
General advice on exercise
Modified paleolithic diet and general advice on exercise
Modified paleolithic diet and general advice on exercise
Modified paleolithic diet and general advice on exercise
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* BMI 27-35
* women only after menopause
* diabetes treatment with diet and/or metformin
* HbA1c between 45 and 94
Exclusion Criteria
* 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
30 Years
65 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Tommy Olsson
Professor
Principal Investigators
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Tommy Olsson, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Public Health and Clinical Medicine, Umeå University
Locations
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Department of Public Health and Clinical Medicine, Medicine
Umeå, , Sweden
Countries
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References
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Otten J, Andersson J, Stahl J, Stomby A, Saleh A, Waling M, Ryberg M, Hauksson J, Svensson M, Johansson B, Olsson T. Exercise Training Adds Cardiometabolic Benefits of a Paleolithic Diet in Type 2 Diabetes Mellitus. J Am Heart Assoc. 2019 Jan 22;8(2):e010634. doi: 10.1161/JAHA.118.010634.
Otten J, Stomby A, Waling M, Isaksson A, Soderstrom I, Ryberg M, Svensson M, Hauksson J, Olsson T. A heterogeneous response of liver and skeletal muscle fat to the combination of a Paleolithic diet and exercise in obese individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2018 Jul;61(7):1548-1559. doi: 10.1007/s00125-018-4618-y. Epub 2018 Apr 26.
Stomby A, Otten J, Ryberg M, Nyberg L, Olsson T, Boraxbekk CJ. A Paleolithic Diet with and without Combined Aerobic and Resistance Exercise Increases Functional Brain Responses and Hippocampal Volume in Subjects with Type 2 Diabetes. Front Aging Neurosci. 2017 Dec 4;9:391. doi: 10.3389/fnagi.2017.00391. eCollection 2017.
Otten J, Stomby A, Waling M, Isaksson A, Tellstrom A, Lundin-Olsson L, Brage S, Ryberg M, Svensson M, Olsson T. Benefits of a Paleolithic diet with and without supervised exercise on fat mass, insulin sensitivity, and glycemic control: a randomized controlled trial in individuals with type 2 diabetes. Diabetes Metab Res Rev. 2017 Jan;33(1):10.1002/dmrr.2828. doi: 10.1002/dmrr.2828. Epub 2016 Jun 30.
Other Identifiers
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Dnr 2011-294-31M
Identifier Type: -
Identifier Source: org_study_id
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