The Boden Initiative Clinical Trials

This study is recruiting participants with BMI ≥ 27 kg/m² and a history or stroke, myocardial infarction or peripheral vascular disease. Participants will receive the investigational agent or the placebo for approximately 3 years. During this time participants will attend study visits at the Charles Perkins Centre once every month (travel reimbursement is provided). Participants will be supported by accredited dietitians to make healthful changes to diet and physical activity.

Inclusion criteria:

• age ≥ 45 years
• BMI ≥ 27 kg/m²

And

History of any of the following:

• blocked artery or stent insertion for blocked artery (in heart, neck, or limbs)
• myocardial infarction
• coronary artery bypass graft (also known as CABG, coronary bypass)
• stroke
• chronic kidney disease
• diagnosed peripheral vascular disease or amputation due to peripheral vascular disease.

Ethics committee approval has been granted by Sydney Local Health District [X24-013]

This study is recruiting participants with BMI 27-40 kg/m2 and Type II diabetes. Participants will undergo a medical procedure performed endoscopically under anaesthesia to deliver either pulsed electric energy to the small intestine or no treatment at all (the control group). Delivering electric energy to the cells of the lining of the small intestine is designed to cause the cells to regenerate which may improve blood glucose control. All participants will receive monthly lifestyle modification counselling with accredited dietitians for 12 months. After completing the 12-month study, participants who did not receive the treatment initially (the control group) will be offered the treatment and then complete another 12 months of being on the study with monthly dietitian consults. 

Inclusion criteria:

• Age 22-70 years inclusive
• BMI 27-40 kg/m2
• Diagnosed with Type II Diabetes ≥ 6 months 
• Do not use insulin

Ethics committee approval has been granted by Sydney Local Health District [X24-0249].

A randomised, controlled trial to see whether tirzepatide reduces body weight and improves weight related health issues in adolescents with elevated weight and established weight-related health issues

This study is recruiting participants aged 12-17 with elevated body weight and at least two weight-related health issues. Participants will receive the investigational agent (tirzepatide) or placebo for 72 weeks. During the trial participants will attend study visits at the Charles Perkins Centre once every month (travel reimbursement is provided). Dietitians will work with participants and their families to establish healthy dietary and physical activity patterns. 

Inclusion criteria:

• Age 12-17 years 
• Have gone through puberty
• Diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex
• Have at least TWO comorbidities: high blood pressure, prediabetes, high blood fats

Consent for participation in this study must be provided by the participant and their legal representative.

Ethics committee approval has been granted by Sydney Local Health District [X24-0331].

PreBabe is a world-first clinical trial exploring how losing weight prior to pregnancy can improve the long-term health of mothers and babies. Women in Sydney and Newcastle planning a pregnancy are invited to join the PreBabe Trial. We are looking for 2,200 women to take part over the next three years.

Inclusion criteria:

• Women with a BMI > 25, aged 18 to 40 and thinking of becoming pregnant soon are encouraged to register their interest.

Participating women will be offered a free 10-week weight loss program as part of the trial. PreBabe will test two different approaches to losing weight prior to pregnancy to see which has the best short and long-term results for women and babies. Both weight loss programs are safe, supported by a clinical team, and designed to be followed for 10 weeks prior to trying to get pregnant.

The study will generate new knowledge for researchers and healthcare providers to better understand which weight loss approach can best help women with overweight who want to become pregnant. 

Ethics Committee approval has been granted by Sydney Local Health District [2020/ETH02421].