Differences in weight loss using a very low energy diet in obese people with and without diabetes.

In obese subjects with and without diabetes, examining the effect of a very low energy diet (VLED) on weight loss and differences in changes in cardiovascular risk, markers of oxidative stress and advanced glycation, and target organ function.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000133437

Enrollment

Registered

2007-02-19

Start date

2007-04-01

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

Brief summary

Obesity and type 2 diabetes increase the risk of heart, kidney and other disease. A process called oxidative stress is thought to be critical in triggering metabolic changes found in both obesity and diabetes, and thus is a major cause of developing complications from these conditions. The role of weight loss in reducing markers of oxidative stress has not been compared in obese people with and without diabetes. We predict that weight loss in obese patients with diabetes will reduce oxidative stress, and improve kidney and heart dysfunction, to a greater extent than in obese patients without diabetes.

Interventions

A very low energy diet (Optifast). This is a meal replacement diet involving three sachets daily plus one serve of vegetables or salad (600-800kcal/day) for 12 weeks (intensive phase). Subsequently patients are weaned over 8 weeks onto a calorie controlled CSIRO-type diet.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

BMI 30 - 50 kg/m2, diabetes and no diabetes.

Exclusion criteria

Thiazolidinedione therapy, significant comorbidity, previously failed VLED or bariatric surgery.

Outcome results