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

This study is currently recruiting participants.
Verified February 2014 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Tommy Olsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01513798
First received: January 16, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Modified paleolithic diet and exercise under observation
Behavioral: Modified paleolithic diet and general advice on exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Fat mass [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Measured with DEXA (dual energy x-ray absorptiometry)


Secondary Outcome Measures:
  • Peripheral insulin sensitivity [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Measured with euglycemic hyperinsulinemic clamp

  • Hepatic insulin sensitivity [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Measured with euglycemic hyperinsulinemic clamp

  • Liver fat [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Measured with 1H-MRS (proton magnetic resonance spectroscopy)

  • Cortisol turnover [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
  • Appetite regulation [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    GLP-1 (glucagon-like peptide 1), peptide YY

  • Dopamine 2-receptors in striatum [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    PET

  • Executive ability and memory [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    fMRI (functional magnetic resonance imaging)

  • Experience of training [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Actiheart®, food diary, weight, nitrogen excretion

  • Oxygen Uptake [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Cardiopulmonary exercise testing

  • Anaerobic Threshold [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Cardiopulmonary exercise testing

  • Substrate utilization during submaximal exercise [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
    Measured with indirect calorimetry during ergometer cycling


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise under observation
Modified paleolithic diet and exercise 3 sessions/week under observation
Behavioral: Modified paleolithic diet and exercise under observation
Modified paleolithic diet and exercise 3 session/week under observation
Experimental: General advice on exercise
Modified paleolithic diet and general advice on exercise
Behavioral: Modified paleolithic diet and general advice on exercise
Modified paleolithic diet and general advice on exercise

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513798

Contacts
Contact: Julia Otten, MD +46703341559 julia.otten@medicin.umu.se

Locations
Sweden
Department of Public Health and Clinical Medicine, Medicine Recruiting
Umeå, Sweden, 90187
Sub-Investigator: Julia Otten, MD         
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Tommy Olsson, Professor Department of Public Health and Clinical Medicine, Umeå University
  More Information

No publications provided

Responsible Party: Tommy Olsson, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01513798     History of Changes
Other Study ID Numbers: Dnr 2011-294-31M
Study First Received: January 16, 2012
Last Updated: February 4, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Diet Therapy
Exercise Therapy
Insulin Resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014