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Clinical Trials/NCT01513798
NCT01513798
Completed
Not Applicable

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

Umeå University1 site in 1 country40 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Umeå University
Enrollment
40
Locations
1
Primary Endpoint
Fat mass
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tommy Olsson

Professor

Umeå University

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
  • betablockers
  • estrogens orally
  • blod pressure \>160/100
  • macroalbuminuria
  • malignancy during the past 5 years
  • alcoholism
  • depression
  • cardiovascular disease/stroke
  • liver disease

Outcomes

Primary Outcomes

Fat mass

Time Frame: Baseline - 12 weeks

Measured with DEXA (dual energy x-ray absorptiometry)

Secondary Outcomes

  • Hepatic insulin sensitivity(Baseline - 12 weeks)
  • Appetite regulation(Baseline - 12 weeks)
  • Dopamine 2-receptors in striatum(Baseline - 12 weeks)
  • Anaerobic Threshold(Baseline - 12 weeks)
  • Substrate utilization during submaximal exercise(Baseline - 12 weeks)
  • Liver fat(Baseline - 12 weeks)
  • Cortisol turnover(Baseline - 12 weeks)
  • Executive ability and memory(Baseline - 12 weeks)
  • Validity of energy intake and protein intake(Baseline - 6 weeks - 12 weeks)
  • Oxygen Uptake(Baseline - 12 weeks)
  • Peripheral insulin sensitivity(Baseline - 12 weeks)
  • Experience of training(Baseline - 12 weeks)

Study Sites (1)

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