None listed
Conditions
Brief summary
Type 2 diabetes mellitus (T2DM) is closely related to obesity. Previous studies have demonstrated that weight loss is an effective method of improving glycaemic control or even achieving remission of T2DM. Low Energy Diets (LEDs) have been shown to induce weight loss in people with diabetes and improve diabetes outcomes. However, despite their efficacy, they are difficult to maintain owing to hunger. Dulaglutide is a GLP-1 receptor agonist used in the treatment of T2DM. It has multiple positive effects, including a modest weight loss which is at least in part due to an increase in satiety. Whilst both LED and dulaglutide are used in treatment of T2DM, the combination has not previously been explicitly tested. The rationale behind this study is that dulaglutide may improve adherence to a LED by reducing the hunger and food cravings associated with these dietary interventions. We are proposing a pilot study to investigate the safety and tolerability of the combination of dulaglutide and a LED in people with T2DM and and obesity. The study will be unblinded and single arm and will last 12 weeks. Participants will all be treated with 1.5mg weekly dulaglutide and 800 kcal/day dietary replacement using products from the Cambridge Weight Plan.
Interventions
20-25 people with type 2 diabetes mellitus (T2DM) will undergo total dietary replacement with low energy meal replacements from the Cambridge Weight Plan. Dietary replacement will consist of 4 x 200 kcal meal replacements, 2 x cups of non-starchy vegetables and 2.25 L of water per day. This will last for a total of 12 weeks. They will simultaneously be treated with 1.5mg weekly subcutaneous dulaglutide, a GLP-1 receptor agonist. The dulaglutide will be commenced 2 weeks prior to the total dietar
20-25 people with type 2 diabetes mellitus (T2DM) will undergo total dietary replacement with low energy meal replacements from the Cambridge Weight Plan. Dietary replacement will consist of 4 x 200 kcal meal replacements, 2 x cups of non-starchy vegetables and 2.25 L of water per day. This will last for a total of 12 weeks. They will simultaneously be treated with 1.5mg weekly subcutaneous dulaglutide, a GLP-1 receptor agonist. The dulaglutide will be commenced 2 weeks prior to the total dietary replacement phase and will therefore be given for a total of 14 weeks. Adherence to the intervention will be monitored through fortnightly contact, either face-to-face or by telephone.
Sponsors
Waitemata District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Able and willing to give written informed consent • Men and women aged 20-65 years, all ethnicities • T2DM of duration 0-6 years • Eligible for funded dulaglutide under New Zealand PHARMAC special authority criteria • Body mass index (BMI)>27 kg/m2 and <45 kg/m2
Exclusion criteria
• Most recent HbA1c greater than 108mmol/mol (12%) • Most recent eGFR less than 30 mls/min/1.732 • Substance abuse • Known cancer • Myocardial infarction or stroke within previous 6 months • Learning difficulties • Current treatment with anti-obesity drugs • Diagnosed eating disorder or purging • Pregnant or considering pregnancy • People who have required hospitalisation for depression or are on antipsychotic drugs • People currently participating in another clinical research trial • People taking a monoamine oxidase inhibitor
Outcome results
None listed