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

February 25, 2015 updated by: Tommy Olsson, Umeå University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 90187
        • Department of Public Health and Clinical Medicine, Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: Baseline - 12 weeks
Measured with DEXA (dual energy x-ray absorptiometry)
Baseline - 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral insulin sensitivity
Time Frame: Baseline - 12 weeks
Measured with euglycemic hyperinsulinemic clamp
Baseline - 12 weeks
Hepatic insulin sensitivity
Time Frame: Baseline - 12 weeks
Measured with euglycemic hyperinsulinemic clamp
Baseline - 12 weeks
Liver fat
Time Frame: Baseline - 12 weeks
Measured with 1H-MRS (proton magnetic resonance spectroscopy)
Baseline - 12 weeks
Cortisol turnover
Time Frame: Baseline - 12 weeks
Baseline - 12 weeks
Appetite regulation
Time Frame: Baseline - 12 weeks
GLP-1 (glucagon-like peptide 1), peptide YY
Baseline - 12 weeks
Dopamine 2-receptors in striatum
Time Frame: Baseline - 12 weeks
PET
Baseline - 12 weeks
Executive ability and memory
Time Frame: Baseline - 12 weeks
fMRI (functional magnetic resonance imaging)
Baseline - 12 weeks
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)
Baseline - 12 weeks
Validity of energy intake and protein intake
Time Frame: Baseline - 6 weeks - 12 weeks
Actiheart®, food diary, weight, nitrogen excretion
Baseline - 6 weeks - 12 weeks
Oxygen Uptake
Time Frame: Baseline - 12 weeks
Cardiopulmonary exercise testing
Baseline - 12 weeks
Anaerobic Threshold
Time Frame: Baseline - 12 weeks
Cardiopulmonary exercise testing
Baseline - 12 weeks
Substrate utilization during submaximal exercise
Time Frame: Baseline - 12 weeks
Measured with indirect calorimetry during ergometer cycling
Baseline - 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Tommy Olsson, Professor, Department of Public Health and Clinical Medicine, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2011-294-31M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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