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

This study is currently recruiting participants.

Verified January 2012 by Umeå University

Sponsor:

Information provided by (Responsible Party):

Tommy Olsson, Umeå University

ClinicalTrials.gov Identifier:

NCT01513798

First received: January 16, 2012

Last updated: January 30, 2012

Last verified: January 2012

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

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

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 clamå
Liver fat [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
Measured with H-MRS
Cortisol turnover [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
Apetite regulation [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
GLP-1, peptid 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
Experience of training [ Time Frame: Baseline - 12 weeks ] [ Designated as safety issue: No ]
SCI ESES, ABC, PRETIE-Q
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 calometry during ergometer cycling

Estimated Enrollment:	40
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (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
oficial weight loosing program during the past year
obesity surgery
night work
MADRS-S > 20 points
AUDIT > 14 points for women, >16 points for men
not possible to get in a venflone for the study

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:	January 30, 2012
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 May 19, 2013

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