NCT02590822: Diastolic

Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction

Recruiting now NA Last updated 5 January 2024

What this trial tests

NA trial testing Cambridge Weight Plan in Diabetes in 120 participants. Currently enrolling.

Timeline

2 October 2015

Primary endpoint
31 August 2028

31 August 2028

Quick facts

Lead sponsor	University of Leicester
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	2 October 2015
Primary completion	31 August 2028
Estimated completion	31 August 2028
Sites	1 location across United Kingdom

Drugs / interventions tested

• Cambridge Weight Plan
• Supervised Exercise Sessions

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

University of Leicester

Who can join

Adults 18 to 65, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is an epidemic of type 2 diabetes in younger adults. These patients are at very high lifetime risk of heart-related complications. Subtle heart abnormalities can be present even at a young age in these patients and may predispose them to heart failure and ultimately premature death. There is emerging evidence that type 2 diabetes can be reversed with weight loss. We propose that weight loss can also reverse the fatty changes seen in the liver and heart in these patients, and in turn lead to improved heart function.

This project aims to identify how type 2 diabetes causes changes in the heart in young people with type 2 diabetes by performing detailed scans and other tests of the heart's structure and function. In addition we will attempt to see if the heart's pumping function can be improved, either by a weight loss program with a special low calorie diet, or by a structured program of exercise. This will be compared with the usual standard diabetes care.

As well as looking to see if the heart's function can be improved with the intervention, we also aim to identify what the mechanism of any improvement would be. We suspect that changes in the amount of fat within the liver and the heart may be responsible, and will measure these at the beginning, end and in some patients halfway through the study to explore possible mechanisms amongst other clinical variables (e.g. HbA1c)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study).
   Gulsin GS, Brady EM, Swarbrick DJ, Athithan L, et al · · 2019 · cited 20× · PMID 30928925 · DOI 10.1136/bmjopen-2018-023207
2. Age at diagnosis of type 2 diabetes and cardiovascular risk factor profile: A pooled analysis.
   Barker MM, Zaccardi F, Brady EM, Gulsin GS, et al · · 2022 · cited 13× · PMID 35432761 · DOI 10.4239/wjd.v13.i3.260
3. The impact of lifestyle intervention on left atrial function in type 2 diabetes: results from the DIASTOLIC study.
   Alfuhied A, Gulsin GS, Athithan L, Brady EM, et al · · 2022 · cited 7× · PMID 35233724 · DOI 10.1007/s10554-022-02578-z
4. Circulating sphingolipids and relationship to cardiac remodelling before and following a low-energy diet in asymptomatic Type 2 Diabetes.
   Brady EM, Cao TH, Moss AJ, Athithan L, et al · · 2024 · cited 6× · PMID 38172712 · DOI 10.1186/s12872-023-03623-y
5. Fibro-inflammatory recovery and type 2 diabetes remission following a low calorie diet but not exercise training: A secondary analysis of the DIASTOLIC randomised controlled trial.
   Brady EM, Gulsin GS, Mirkes EM, Parke K, et al · · 2022 · cited 6× · PMID 35587779 · DOI 10.1111/dme.14884
6. Interrelationship between micronutrients and cardiovascular structure and function in type 2 diabetes.
   Walters GWM, Walters GWM, Redman E, Gulsin GS, et al · · 2021 · cited 4× · PMID 34733500 · DOI 10.1017/jns.2021.82
7. Clinical associations with stage B heart failure in adults with type 2 diabetes.
   Gulsin GS, Brady E, Marsh AM, Squire G, et al · · 2021 · cited 4× · PMID 34349975 · DOI 10.1177/20420188211030144
8. Sex differences and determinants of coronary microvascular function in asymptomatic adults with type 2 diabetes.
   Yeo JL, Dattani A, Bilak JM, Wood AL, et al · · 2025 · cited 2× · PMID 39647765 · DOI 10.1016/j.jocmr.2024.101132