Trial · Interventional

CompletedPhase 4Registry data

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

Short name Lean-DM

NCTNCT04657939Other id265208Other id18/0005908Other id19/WM/0365

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 57 participants (actual)
Sponsor: University of Leeds · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United Kingdom
Start: 1 Dec 2020
Primary completion: 31 Oct 2022
Completion: 31 Oct 2022
First posted: 8 Dec 2020
Last update posted: 27 Feb 2023
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 4
Lean-DM
NCT04657939
1 Dec 2020 to 31 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
PioglitazoneDrug

Arms2

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 outcomes1

Outcomes the sponsor listed as primary.

Change in myocardial perfusion after treatment
Time frame · 40 weeks
Registry description
Measured changes in myocardial perfusion by Magnetic Resonance Imaging (MRI) after treatment with liraglutide and pioglitazone.

Secondary outcomes(7)

Myocardial energetics (PCr/ATP ratio)
Time frame · 40 weeks
Registry description
Change in myocardial energetics as measured by MRI after treatment
Myocardial steatosis (myocardial triglyceride content)
Time frame · 40 weeks
Registry description
Change in myocardial steatosis as measured by MRI after treatment
Myocardial function
Time frame · 40 weeks
Registry description
Change in myocardial function as measured by MRI after treatment
Insulin resistance (HOMA-IR)
Time frame · 40 weeks
Registry description
Change in HOMA-IR as determined by blood results after treatment
Physical performance
Time frame · 40 weeks
Registry description
Change in physical performance as measured by 6 minute walk test after treatment
Hepatic steatosis (hepatic triglyceride content)
Time frame · 40 weeks
Registry description
Change in hepatic steatosis as measured by MRI after treatment
Peripheral endothelial function
Time frame · 40 weeks
Registry description
Changes in peripheral endothelial function as measured by EndoPAT after treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

5 results

Liraglutide Improves Myocardial Perfusion and Energetics and Exercise Tolerance in Patients With Type 2 Diabetes.

Chowdhary et al. 2024Journal of the American College of Cardiologycited by 27

PMID 39084829PMC11296502DOI 10.1016/j.jacc.2024.04.064PUB-39084829

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: Lean cohort 1. Men and women\>18 years of age; 2. Normal body weight (18.5 ≤ BMI ≤25 kg/m2); 3. T2D patients can be on treatment with oral glucose lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening; 4. 6.5≤HBA1c≤10% at screening; 5. Agreement to maintain prior diet and exercise habits for the duration of the study. Overweight cohort 1. Men and women\>18 years of age; 2. Increased body weight (BMI \>27 kg/m2); 3. T2D patients can be on treatment with oral glucose lowering therapies, and must have been on these treatments for at least 12 weeks prior to screening; 4. 6.5≤HBA1c≤10% at screening; 5. Agreement to maintain prior diet and exercise habits for the duration of the study. Exclusion Criteria: 1. Any type of diabetes other than T2D; 2. Past history of significant CAD; 3. Known HF; 4. Significant renal impairment (eGFR\<30ml/min/m2); 5. Participation in a clinical trial of an investigational medicinal product (CTIMP) in the preceding 12 weeks; 6. Known hypersensitivity to dobutamine or gadolinium or any other contra-indications to MRI; 7. Participants with obesity where their girth exceeds the scanner bore; 8. History of pancreatitis; 9. Any history of liver disease; 10. Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); 11. Prior or current use of thiazolidinediones (aka PPAR-γ agonists), fibrates, GLP-1RA or insulin; 12. Patients that are pregnant (female participants only); 13. Inflammatory bowel disease 14. Diabetic gastroparesis

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