Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04009642
Other study ID # 0633
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2018
Est. completion date March 1, 2020

Study information

Verified date April 2021
Source University of Leicester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The number of people with diabetes is rising. One of the major causes of premature death in diabetes is heart failure (HF). This is when the heart cannot pump blood effectively, and this may be related to abnormalities in energy production in the heart muscle. In healthy people, the heart muscle cells show flexibility and can use both sugar and fat molecules for energy production. Although burning fat provides more energy, this process requires more oxygen than burning sugars. As a result, fat is a less efficient fuel for the heart compared to sugars, especially in situations where the energy and oxygen needs are higher, such as during exercise. The investigators propose that the heart muscle in patients with type 2 diabetes relies heavily on fat for energy provision, and fails to burn more sugar molecules for energy provision during exercise to more efficiently use oxygen. Fat and sugar uptake by the heart can be detected by the difference between the blood sugar and fat levels delivered to the heart and returning from the heart, both at rest and also when the heart is working faster during Dobutamine infusion. Dobutamine is a drug frequently used to mimic exercise, and get the heart running faster during medical tests. To test the hypothesis, the investigators will assess fat and sugar uptake by the heart at rest and when the heart is running faster, in patients with type 2 diabetes undergoing investigations to rule out coronary disease. Heart function, and blood supply to heart muscle, at rest and during Dobutamine infusion, will also be measured using MRI scanning. The same tests will be performed in people without diabetes for comparison. It will help understand diabetic heart disease and which aspects may be targeted with new treatments.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Group 1: Type 2 diabetes cohort: 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Confirmed diagnosis of T2D according to World Health Organisation (WHO) criteria 4. Undergoing invasive coronary angiography for exclusion of CAD. 5. Able (in the investigator's opinion) and willing to comply with all study requirements 6. Must understand written and verbal English Group 2: Non-diabetic Controls 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Undergoing invasive coronary angiography for exclusion of CAD. 4. Able (in the investigator's opinion) and willing to comply with all study requirements. Exclusion Criteria: Group 1 1. Type 1 diabetes. 2. Significant CAD> (50% luminal stenosis) 3. Significant renal impairment (eGFR<30ml/min/m2). 4. Previous coronary artery bypass grafting surgery or myocardial infarction 5. Significant clinical established diagnosis of heart failure and EF <40% 6. Female participants who are pregnant, lactating or planning pregnancy during the course of the study. 7. Participants who have participated in another research study involving an investigational product in the past 12 weeks 8. Atrial fibrillation. 9. Contra-indications to magnetic resonance imaging (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia). 10. Known hypersensitivity to dobutamine or gadolinium. 11. Participants with a diagnosis of significant (>moderate,) valve disease. 1. Patients who are on Insulin therapy, or oral Thiazolidinedione. 2. Involvement in other studies thought to compromise resulting study data or the health of the participant in the opinion of investigator. Group 2 1. As per group 1 plus 2. Diagnosis of diabetes or impaired glucose tolerance Note patients with previous CAD treated by angioplasty/stenting and no residual disease are eligible.

Study Design


Intervention

Other:
Surely observational based on disease state
Metabolism in T2DM vs non diabetic

Locations

Country Name City State
United Kingdom Glenfield Hospital, University Hospitals of Leicester NHS Trust Leicester

Sponsors (1)

Lead Sponsor Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in myocardial FA extraction fraction (%) between T2D patients and non-diabetic controls at rest. Myocardial extraction fraction Immediate at rest and stress
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2