Clinical trial NCT01513798: Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
Official title: Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diet Therapy
Exercise Therapy
Insulin Resistance
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fat mass
timeFrame: Baseline - 12 weeks
Secondary outcomes:
measure: Peripheral insulin sensitivity
timeFrame: Baseline - 12 weeks
measure: Hepatic insulin sensitivity
timeFrame: Baseline - 12 weeks
measure: Liver fat
timeFrame: Baseline - 12 weeks
measure: Cortisol turnover
timeFrame: Baseline - 12 weeks
measure: Appetite regulation
timeFrame: Baseline - 12 weeks
measure: Dopamine 2-receptors in striatum
timeFrame: Baseline - 12 weeks
measure: Executive ability and memory
timeFrame: Baseline - 12 weeks
measure: Experience of training
timeFrame: Baseline - 12 weeks
measure: Validity of energy intake and protein intake
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Oxygen Uptake
timeFrame: Baseline - 12 weeks
measure: Anaerobic Threshold
timeFrame: Baseline - 12 weeks
measure: Substrate utilization during submaximal exercise
timeFrame: Baseline - 12 weeks
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Public Health and Clinical Medicine, Medicine
Study officials:
affiliation: Department of Public Health and Clinical Medicine, Umeå University
name: Tommy Olsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.