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

A randomised study to evaluate High protein diets and resistance exercise training in type 2 diabetes study 2008

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000206325
Acronym
PE
Enrollment
100
Registered
2008-04-17
Start date
2008-03-03
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

16 week low fat (20% of energy) weight loss diet intervention of either high carbohydrate (55%) or high protein (35%) dietary composition. 3 of 5 groups will also participate in a whole body moderate intensity resistance exercise training program. Training sessions of 30 minutes duration held 3 times per week for 16 weeks.

Sponsors

Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 10, 2026