DOMINO trial
Research type
Research Study
Full title
Investigation of the metabolic effects of duodenal resurfacing on insulin resistant women wIth polycystic ovarian syndrome
IRAS ID
225278
Contact name
Alexander Miras
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Research Summary
Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder affecting women. Clinical manifestations include reduced or absent menstrual cycles, excess hair growth, and infertility. Moreover, women with PCOS have an increased rate of obesity, with a propensity toward abdominal deposition of body fat and insulin resistance. This leads to a number of comorbidities including metabolic syndrome, hypertension, dyslipidaemia, glucose intolerance, and type 2 diabetes mellitus (T2DM). Llifestyle interventions only work in the short term and is very difficult to maintain and other pharmacological and invasive treatments have high rates of side effects and limited efficacy.
The Fractyl Revita SystemTM is a duodenal mucosal resurfacing (DMR) technology which has achieved CE-marking and a number of studies support its safety and effectiveness in T2DM patients. The procedure is performed endoscopically, without surgery, and under general anaesthesia and in most patients as a day-case. The procedure is very effective for the treatment of patients with T2DM with rapid reductions in blood glucose. It is thought that it works mainly by increasing insulin sensitivity which the predominant mechanism in both T2DM and PCOS.
This will be a prospective double-blinded randomised controlled clinical trial. The setting will be a single multi- centre with tertiary obesity, metabolic medicine and reproductive endocrinology expertise. Thirty female patients will be recruited from the obesity and reproductive clinics at Imperial College NHS Trust or other patient identification sites, and randomised to either DMR or the sham procedure. The procedures will be performed at Imperial College Healthcare NHS Trust and King’s College Hospital NHS Trust.
Both groups will receive standard NHS Tier 3 lifestyle advice and support for the duration of the trial. Lifestyle modification will be delivered by a dietician and psychologist in monthly group or individual sessions for a period of 6 months.
In this trial we will investigate both whether this non-invasive device indeed increases insulin sensitivity using gold-standard methodologies but also whether it can help women of reproductive age start menstruating.
Summary of results
Background: Duodenal mucosal resurfacing (DMR) is a novel day-case endoscopic treatments which improves glucose control in people with type 2 diabetes mellitus (T2DM). We hypothesized that DMR works by increasing sensitivity to insulin.
Methods: Thirty-two insulin-resistant women with polycystic ovary syndrome (PCOS) and obesity were randomised to DMR or sham endoscopy (no actual treatment). They underwent measurements of insulin sensitivity using "insulin clamps".
Results: A small increase in sensitivity to insulin measured by the clamp was observed in both groups at week 12. An increase in insulin sensitivity, as measured by another blood test, was observed in both groups at week 24. There were no significant differences between the two groups.
Conclusions: These findings suggest that DMR does not work by increasing insulin sensitivity in women with PCOS. The procedure may exert its effects only in people with T2DM.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1095
Date of REC Opinion
7 Aug 2017
REC opinion
Further Information Favourable Opinion