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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014