Insulin Dose Adjustments for Meals Differing in Fat Content in T1DM

NCT02595658 | Completed DMC

• 1 other identifier: West-Walker4
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Glycaemic responses. Assessed via venous blood concentrations at periodic intervals.

  6 hours

Secondary Outcomes (4)

• Lipaemic responses. Assessed via venous blood concentrations at periodic intervals.

  6 hours

• Interstitial glucose responses. Assessed using real-time continuous glucose monitoring throughout the duration of the study

  24 hours

• Inflammatory responses. Assessed via venous blood concentrations at periodic intervals.

  6 hours

• Appetite responses. Assessed via subjective visual analogue scales at periodic intervals

  6 hours

Study Arms (4)

1

EXPERIMENTAL

Carbohydrate only meal: Participants will consume a standardised carbohydrate meal (80 g of carbohydrates, 25 g protein, 0 g fat: meal composition, white rice, chicken, curry sauce; 420 kcal) and will self-administer (into the subcutaneous tissue of the abdomen, as per their regular routine) a rapid-acting insulin dose calculated as per the carbohydrate-counting ratio (e.g. 1 IU of insulin per 10 g of carbohydrates).

Dietary Supplement: Meal composition

2

EXPERIMENTAL

Participants will replicate Trial 1, but on this occasion the meal consumed will have an additional 50 g of fat (via addition of Ghee). This fat will be added to the sauce within the meal (80 g of carbohydrates, 25 g of protein, 50 g of fat; 735 Kcal). Participants will administer their rapid-acting insulin as per the carbohydrate counting method (i.e. the same IU of insulin as per Trial 1).

Dietary Supplement: Meal composition

3

EXPERIMENTAL

Trial 3) Participants will replicate Trial 2, but will administer a rapid-acting insulin dose that has been increased by 30%.

Dietary Supplement: Meal composition; Drug: Rapid-Acting Insulin Dose

4

EXPERIMENTAL

Participants will replicate Trial 2, but will administer an additional rapid-acting insulin dose of 30% 3 hrs post-meal.

Dietary Supplement: Meal composition; Drug: Rapid-Acting Insulin Dose

Interventions

Meal composition DIETARY_SUPPLEMENT

1; 2; 3; 4

Rapid-Acting Insulin Dose DRUG

3; 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• either male or female and aged 18-50 years old
• free from any diabetes complications apart from background diabetic retinopathy
• not taking any prescribed medication other than insulin
• treated with a stable insulin regimen composed of a combination of slow/long acting insulin glargine/determir and a fast acting insulin analogue (lispro or aspart, glulisine)
• have a HbA1c of \<9.5% (80 mmol/mol)
• using the carbohydrate counting method for administering meal time rapid-acting insulin.

Sponsors & Collaborators

• Northumbria University: lead

Related Publications (1)

• Campbell MD, West DJ, O'Mahoney LL, Pearson S, Kietsiriroje N, Holmes M, Ajjan RA. The relative contribution of diurnal and nocturnal glucose exposures to HbA1c in type 1 diabetes males: a pooled analysis. J Diabetes Metab Disord. 2022 Mar 31;21(1):573-581. doi: 10.1007/s40200-022-01015-1. eCollection 2022 Jun.

  PMID: 35673512 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 4, 2021

Record last verified: 2021-03