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Completed

NCT Number: NCT01513798

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health and Clinical Medicine, Medicine

Umeå, 90187, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified paleolithic diet and exercise under observation

Behavioral

Modified paleolithic diet and exercise 3 session/week under observation

Modified paleolithic diet and general advice on exercise

Behavioral

Modified paleolithic diet and general advice on exercise

Primary outcomes

  1. Fat mass

    Time frame: Baseline - 12 weeks

    Measured with DEXA (dual energy x-ray absorptiometry)

Secondary outcomes

  1. Peripheral insulin sensitivity

    Time frame: Baseline - 12 weeks

    Measured with euglycemic hyperinsulinemic clamp

  2. Hepatic insulin sensitivity

    Time frame: Baseline - 12 weeks

    Measured with euglycemic hyperinsulinemic clamp

  3. Liver fat

    Time frame: Baseline - 12 weeks

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

  4. Cortisol turnover

    Time frame: Baseline - 12 weeks

  5. Appetite regulation

    Time frame: Baseline - 12 weeks

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

  6. Dopamine 2-receptors in striatum

    Time frame: Baseline - 12 weeks

    PET

  7. Executive ability and memory

    Time frame: Baseline - 12 weeks

    fMRI (functional magnetic resonance imaging)

  8. 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)

  9. Validity of energy intake and protein intake

    Time frame: Baseline - 6 weeks - 12 weeks

    Actiheart®, food diary, weight, nitrogen excretion

  10. Oxygen Uptake

    Time frame: Baseline - 12 weeks

    Cardiopulmonary exercise testing

  11. Anaerobic Threshold

    Time frame: Baseline - 12 weeks

    Cardiopulmonary exercise testing

  12. Substrate utilization during submaximal exercise

    Time frame: Baseline - 12 weeks

    Measured with indirect calorimetry during ergometer cycling

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2012
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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