Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes

Sponsor
University of Leeds
Study ID
NCT04657939
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide 0.6mg once daily by subcutaneous injection escalated to 1.2mg after 2 weeks.
  • Pioglitazone — DRUG
    Pioglitazone 15mg once daily tablets taken orally escalated to 30mg after 2 weeks then escalated to 45mg after another 2 weeks.

Study Details

The majority of people with type 2 diabetes (T2D) are overweight, and while weight gain is a major contributor to diabetes, a minority of patients with T2D are not overweight or obese. The reasons why lean or normal body weight individuals develop T2D (lean-T2D) are not yet understood. T2D occurs when the body does not produce enough insulin, or becomes less sensitive to its effects. Insulin acts like a key to allow sugar into cells and if someone is overweight that key works less well. Recent research suggests that T2D in lean people should be considered a different disease from the diabetes associated with obesity and the main problem in lean-T2D patients may be a reduced capacity of insulin secretion. However, some researchers argue that many seemingly thin people carry more fat than muscle, making them trim on the outside, but fat on the inside, and they are in fact not truly lean. This implies that just like overweight diabetics, lean diabetics also have high resistance to insulin. The main aim of this research is to better understand the main driver of T2D in lean individuals, as this will determine how best to treat these individuals. There are many different types of drugs for treating T2D. Liraglutide improves insulin secretion capacity of the pancreas. Pioglitazone reduces resistance to insulin action. The investigators will compare the actions of these diabetes drugs on the blood supply and the heart's energy levels in lean-T2D and obese-T2D patients. This will allow the investigators to determine the ideal treatment strategies for improving cardiovascular health in lean-T2D patients, and better understand the role of impaired insulin secretory capacity, insulin resistance and excess fat deposition specifically in this group.

Key Dates

Start date
Dec 1, 2020
Status verified
Feb 2023
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide-Pioglitazone
    Participants randomised to receive liraglutide treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with pioglitazone.
  • Active Comparator: Pioglitazone-Liraglutide
    Participants randomised to receive pioglitazone treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with liraglutide.

Primary Outcome Measure

Change in myocardial perfusion after treatment [ Time Frame: 40 weeks ]

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