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Insulin Dose Adjustments for Meals Differing in Fat Content in T1DM

NCT02595658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-03-04

No results posted yet for this study

Summary

People with Type 1 diabetes (T1DM) are usually provided guidance on how best to control glycaemia around meal times through adjusting their rapid-acting insulin dose according to the carbohydrate content of the meal (e.g. 1 IU per 10/15 g of carbohydrate; Schmidt et al., 2014). However, a potential issue around this method is the role of dietary fat in the calculation of insulin requirements (Wolpert et al., 2013). The fat component of the meal has the potential to influence the insulin dose requirement to normalise postprandial glycaemia (Wolpert et al., 2013). Although normalising postprandial glycaemia is vital, postprandial lipaemia is also an important consideration for long-term health, and at present there is scant data in this area in T1DM. In addition, changing the macronutrient composition of foods and altering insulin doses may carry important implications for vascular function and prospective appetite regulation.

This research will examine the glycaemic and lipaemic responses after consuming a mixed meal similar in carbohydrate content, but differing in fat content. Moreover, this research will assess whether acute postprandial reductions in insulin sensitivity can be offset through increasing the dose of rapid-acting insulin for such meals. Venous blood samples will be collected before and for 6 hours after meals, for the determination of glycaemic and lipaemic responses, as well as metabolite and hormonal parameters. In addition this study will assess the impact of mixed meals and adjusting insulin dose on vascular function and subjective ratings of appetite.

The findings from this study will benefit patients with type 1 diabetes by the provision of more refined self-management strategies for insulin dosage around meal-times.

Conditions

  • Low Fat Meal - Unadjusted Insulin Dose
  • High Fat Meal - Unadjusted Insulin Dose
  • High Fat Meal - Adjusted Insulin Dose +30 Percent
  • High Fat Meal - Adjusted Insulin Dose +Split Dose

Interventions

DIETARY_SUPPLEMENT

Meal composition

DRUG

Rapid-Acting Insulin Dose

Sponsors & Collaborators

  • Northumbria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595658 on ClinicalTrials.gov