TWO BIRDS - Intensive lifestyle and medication to help improve diabetes and fatty liver disease through weight loss

Not Applicable

Recruiting

• Conditions: Obesity; Type 2 Diabetes; Non-alcoholic fatty liver disease; Hypertension; Hyperlipidaemia; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cardiovascular - Hypertension

• Registration Number: ACTRN12619000931178
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.BMI>35 kg/m2
2.Age 18-75 years of age
3.Have a diagnosis of type 2 diabetes mellitus with (HbA1c > 6.5%).
4.Have a diagnosis duration of T2D < 6 years
5.No clear contraindications to treatment with either very low calorie diets (VLCD) and/or glucagon-like peptide-1 (GLP-1) receptor analogues.

Exclusion Criteria

Individuals with: Type 1 diabetes; pregnant or planning pregnancy; significant alcohol or drug abuse; severe/untreated mental health illnesses, including eating disorders; advanced cardiac, liver or renal disease; individuals taking sodium glucose co-transporter 2 receptor blockers and/or exenatide immediate release (Byetta ®) (will need to cease medications for at least 2 weeks prior to study commencement); individuals taking medications that affect weight within the past 1 month (e.g., corticosteroids, phentermine, topiramate, naltrexone, bupropion); contraindications to following VLCD (Vegan diet, lactose intolerance); recent history of pancreatitis or acute coronary event/revascularisation in the most recent 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes remission (defined as an HbA1c < 6.5% on blood test) at the conclusion of the study period whilst off all diabetes therapies for 3-months OR HbA1c<6.0% whilst on metformin only[8 months post enrolment]