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

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ClinicalTrials.gov Identifier: NCT01513798
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Tommy Olsson, Umeå University

January 16, 2012
January 20, 2012
February 26, 2015
January 2012
August 2014   (Final data collection date for primary outcome measure)
Fat mass [ Time Frame: Baseline - 12 weeks ]
Measured with DEXA (dual energy x-ray absorptiometry)
Fat mass [ Time Frame: Baseline - 12 weeks ]
Measured with DEXA
Complete list of historical versions of study NCT01513798 on ClinicalTrials.gov Archive Site
  • Peripheral insulin sensitivity [ Time Frame: Baseline - 12 weeks ]
    Measured with euglycemic hyperinsulinemic clamp
  • Hepatic insulin sensitivity [ Time Frame: Baseline - 12 weeks ]
    Measured with euglycemic hyperinsulinemic clamp
  • Liver fat [ Time Frame: Baseline - 12 weeks ]
    Measured with 1H-MRS (proton magnetic resonance spectroscopy)
  • Cortisol turnover [ Time Frame: Baseline - 12 weeks ]
  • Appetite regulation [ Time Frame: Baseline - 12 weeks ]
    GLP-1 (glucagon-like peptide 1), peptide YY
  • Dopamine 2-receptors in striatum [ Time Frame: Baseline - 12 weeks ]
    PET
  • Executive ability and memory [ Time Frame: Baseline - 12 weeks ]
    fMRI (functional magnetic resonance imaging)
  • Experience of training [ Time Frame: 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)
  • Validity of energy intake and protein intake [ Time Frame: Baseline - 6 weeks - 12 weeks ]
    Actiheart®, food diary, weight, nitrogen excretion
  • Oxygen Uptake [ Time Frame: Baseline - 12 weeks ]
    Cardiopulmonary exercise testing
  • Anaerobic Threshold [ Time Frame: Baseline - 12 weeks ]
    Cardiopulmonary exercise testing
  • Substrate utilization during submaximal exercise [ Time Frame: Baseline - 12 weeks ]
    Measured with indirect calorimetry during ergometer cycling
  • Peripheral insulin sensitivity [ Time Frame: Baseline - 12 weeks ]
    Measured with euglycemic hyperinsulinemic clamp
  • Hepatic insulin sensitivity [ Time Frame: Baseline - 12 weeks ]
    Measured with euglycemic hyperinsulinemic clamå
  • Liver fat [ Time Frame: Baseline - 12 weeks ]
    Measured with H-MRS
  • Cortisol turnover [ Time Frame: Baseline - 12 weeks ]
  • Apetite regulation [ Time Frame: Baseline - 12 weeks ]
    GLP-1, peptid YY
  • Dopamine 2-receptors in striatum [ Time Frame: Baseline - 12 weeks ]
    PET
  • Executive ability and memory [ Time Frame: Baseline - 12 weeks ]
    fMRI
  • Experience of training [ Time Frame: Baseline - 12 weeks ]
    SCI ESES, ABC, PRETIE-Q
  • Validity of energy intake and protein intake [ Time Frame: Baseline - 6 weeks - 12 weeks ]
    Actiheart®, food diary, weight, nitrogen excretion
Not Provided
Not Provided
 
Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Behavioral: Modified paleolithic diet and exercise under observation
    Modified paleolithic diet and exercise 3 session/week under observation
  • Behavioral: Modified paleolithic diet and general advice on exercise
    Modified paleolithic diet and general advice on exercise
  • Experimental: Exercise under observation
    Modified paleolithic diet and exercise 3 sessions/week under observation
    Intervention: Behavioral: Modified paleolithic diet and exercise under observation
  • Experimental: General advice on exercise
    Modified paleolithic diet and general advice on exercise
    Intervention: Behavioral: Modified paleolithic diet and general advice on exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
September 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01513798
Dnr 2011-294-31M
Not Provided
Not Provided
Not Provided
Tommy Olsson, Umeå University
Umeå University
Not Provided
Principal Investigator: Tommy Olsson, Professor Department of Public Health and Clinical Medicine, Umeå University
Umeå University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP