Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Jan 2012
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 16, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 26, 2015
February 1, 2015
2.6 years
January 16, 2012
February 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fat mass
Measured with DEXA (dual energy x-ray absorptiometry)
Baseline - 12 weeks
Secondary Outcomes (12)
Peripheral insulin sensitivity
Baseline - 12 weeks
Hepatic insulin sensitivity
Baseline - 12 weeks
Liver fat
Baseline - 12 weeks
Cortisol turnover
Baseline - 12 weeks
Appetite regulation
Baseline - 12 weeks
- +7 more secondary outcomes
Study Arms (2)
Exercise under observation
EXPERIMENTALModified paleolithic diet and exercise 3 sessions/week under observation
General advice on exercise
EXPERIMENTALModified paleolithic diet and general advice on exercise
Interventions
Modified paleolithic diet and exercise 3 session/week under observation
Modified paleolithic diet and general advice on exercise
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Department of Public Health and Clinical Medicine, Medicine
Umeå, 90187, Sweden
Related Publications (4)
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.
PMID: 30652528DERIVEDOtten 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.
PMID: 29696296DERIVEDStomby 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.
PMID: 29255413DERIVEDOtten 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.
PMID: 27235022DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tommy Olsson, Professor
Department of Public Health and Clinical Medicine, Umeå University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 16, 2012
First Posted
January 20, 2012
Study Start
January 1, 2012
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
February 26, 2015
Record last verified: 2015-02