BridgeMD
New treatment option for Diabetes
Official title Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction
ClinicalTrials.gov ID: NCT02590822
What this study is testing
- What it's testing
- There is an epidemic of type 2 diabetes in younger adults. These patients are at very high lifetime risk of heart-related complications.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Capacity to provide informed consent before any trial-related activities
- Established T2DM (≥3months)
- HbA1c ≤ 9% if on triple therapy or ≤ 10% on diet \& exercise or monotherapy or dual therapy
- Current glucose lowering therapy either mono, dual or triple of any combination of metformin, sulphonylurea, DPP-IV inhibitor, GLP-1 therapy or an...
- Poorly managed diet controlled diabetes (with HbA1c \> 6.5% , not currently taking any glucose lowering therapy, meeting BMI inclusion range)
You likely can't join if
- Diabetes duration \>12 years
- Currently taking more than three glucose lowering therapies
- Weight-loss of \>5kg in the preceding 6 months
- Stage 4 or 5 chronic kidney disease (eGFR\< 30ml/min/1.73m2),
- Current therapy with Insulin, thiazolidinediones, steroids or atypical antipsychotic medication
- Untreated thyroid disease
See the full eligibility criteria
- Capacity to provide informed consent before any trial-related activities
- Established T2DM (≥3months)
- HbA1c ≤ 9% if on triple therapy or ≤ 10% on diet \& exercise or monotherapy or dual therapy
- Current glucose lowering therapy either mono, dual or triple of any combination of metformin, sulphonylurea, DPP-IV inhibitor, GLP-1 therapy or an SGLT2 +/- diet and exercise
- Poorly managed diet controlled diabetes (with HbA1c \> 6.5% , not currently taking any glucose lowering therapy, meeting BMI inclusion range)
- Body mass index \> 30Kg/m2 or \> 27.5 Kg/m2 (South Asian),
- Diagnosis of T2DM before the age of 60 years of age
- Age ≥18 and ≤ 65 years
- Diabetes duration \>12 years
- Currently taking more than three glucose lowering therapies
- Weight-loss of \>5kg in the preceding 6 months
- Stage 4 or 5 chronic kidney disease (eGFR\< 30ml/min/1.73m2),
- Current therapy with Insulin, thiazolidinediones, steroids or atypical antipsychotic medication
- Untreated thyroid disease
- Known macrovascular disease including coronary artery disease, stroke/TIA or peripheral vascular disease
- Presence of arrhythmia (including atrial fibrillation, atrial flutter, or 2nd or 3rd degree atrioventricular block)
- Known heart failure
- Other clinically relevant heart disease
- Inability to exercise or undertake a MRP
- Absolute contraindication to CMR
- Cardiovascular symptoms (angina, limiting dyspnoea during normal physical activity)
- Inflammatory condition e.g. Connective tissue disorder, Rheumatoid arthritis
The study team makes the final eligibility decision.
Where it's taking place
- Leicester, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leicester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.