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2008 weight loss diets and resistance exercise training in type 2 diabetes study

Phase 4
Recruiting
Conditions
Diet and Nutrition - Obesity
Obesity
Type 2 Diabetes
Registration Number
ACTRN12608000206325
Lead Sponsor
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

•Male or female
•Age between 18-65 years
•BMI (body mass index) not greater than 40 or less than 27 (calculated for the volunteers by the research staff based on weight (kg) divided by height (m) squared)
•Have type 2 diabetes (HbA1c < 7.0% or previously diagnosed and controlled with medication)
•Not have type 1 diabetes
•Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
•No abnormality of clinical significance on medical history
•If female, not pregnant or breast feeding

Exclusion Criteria

•BMI(body mass index) greater than 40 or less than 27
•Not have type 2 diabetes (HbA1c < 7.0% or not previously diagnosed and controlled with medication)
•Lactose Intolerant
•Taking Insulin medication
•Have been previously diagnosed with proteinuria, a malignancy, or metabolic disease such as liver, kidney, respiratory, gastrointestinal disease or stroke, or are pregnant or lactating
•Have been previously diagnosed with cardiac disease, including myocardial ischemia or major heart rhythm abnormalities.
•Have high uncontrolled hypertension (resting recumbent BP >160/100 mmHg)
•Have a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain)
•Have severe exercise-induced asthma
•History of smoking during 6 months prior to study
•History of heavy alcohol consumption (> 5 STD drinks/day)
•Volunteer unable to cease alcohol consumption for study duration
•Participated in regular aerobic or resistance exercise program (greater than two 30-min sessions of moderate/vigorous aerobic exercise per week or greater than 1 moderate intensity resistance exercise session per week) during the 6 months prior to study
•Widely fluctuating exercise patterns
•Currently on a weight reducing diet
•Unwilling to be randomized to either experimental group
•Extended absences due to travel or other commitments
•Unable to comprehend or cope with study requirements
•Unable to eat pork and ham on 4 occasions per week
•Unwilling to be randomised to a non-exercise arm

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Whole Body Composition by DEXA (dual energy x-ray absorptiometry) scan.[Week 0 (baseline) and Week 16.];Glycaemic Control (Haemoglobin A1C (HBA1c), Glucose, Insulin from fasting venous blood sample)[Week 0 (baseline) and Week 16.]
Secondary Outcome Measures
NameTimeMethod
Cardiovascular Disease Risk (Blood Lipid Profile, Blood Pressure, Abdominal fat/waist circumference)[Week 0 (baseline) and Week 16.]
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