NCT05231642

Individualised Postprandial Glucose Responses in Type 1 Diabetes

Completed NA Last updated 23 October 2023

What this trial tests

NA trial testing Nutritional Interventional in Type 1 Diabetes in 150 participants. Completed in 20 December 2022.

Timeline

30 November 2021

Primary endpoint
10 December 2022

20 December 2022

Quick facts

Lead sponsor	University of Sunderland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	150
Start date	30 November 2021
Primary completion	10 December 2022
Estimated completion	20 December 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Nutritional Interventional

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →
• Diabetes Complications — all drugs for Diabetes Complications →
• Postprandial Hyperglycemia — all drugs for Postprandial Hyperglycemia →

Sponsor

University of Sunderland

Who can join

Adults 18 to 70, any sex, with Type 1 Diabetes or Diabetes Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Type 1 diabetes (T1D) is a lifelong disease which stops the body from producing insulin - an important hormone that controls blood sugar (glucose) levels. People with T1D use insulin replacement therapy, usually in the form of injections, to help control blood glucose levels, however keeping glucose levels within normal ranges is usually a challenge. Mealtime glucose control is fundamental to good diabetes management and are an important contributor to long-term diabetes complications. However, many individuals experience variability in glucose levels around mealtimes. The objective of this study is to establish whether and which parameters are important predictors of mealtime glucose levels in people with T1D.

The investigators will monitor glucose levels using the latest glucose monitoring technology and collect blood samples to:

1. Characterise changes in glucose levels in individuals with T1D in response to different meals
2. Determine whether and what food characteristics and personal factors are linked to individual glucose responses to different meals.

The investigators will recruit 150 individuals with type 1 diabetes. Firstly participants will attend a preliminary visit, where a blood sample will be donated to study laboratory blood markers of vascular and metabolic health accompanied by a full medical examination in which body composition will be established. During this visit participants will also complete questionnaires about their lifestyle, and be fitted with two wearable devices to monitor glucose levels and physical activity levels under free-living conditions.

After 4-weeks of wearing the devices, participants will attend two experimental laboratory visits where breakfast and lunch will be served and blood samples taken. This will enable us to observe glucose and metabolic responses to feeding under controlled conditions.

Publications & conference data

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

1. Dietary fat intake is associated with insulin resistance and an adverse vascular profile in patients with T1D: a pooled analysis.
   Kietsiriroje N, Shah H, Zare M, O'Mahoney LL, et al · · 2023 · cited 3× · PMID 36495341 · DOI 10.1007/s00394-022-03070-z
2. Plasma levels of mannan-binding lectin-associated serine proteases are increased in type 1 diabetes patients with insulin resistance.
   Kietsiriroje N, Scott GE, Ajjan RA, Brôz J, et al · · 2024 · cited 2× · PMID 37832142 · DOI 10.1093/cei/uxad113