Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin Dose Adjustments for Meals Differing in Fat Content in T1DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595658
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Northumbria University

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.


Condition or disease Intervention/treatment Phase
Low Fat Meal - Unadjusted Insulin Dose High Fat Meal - Unadjusted Insulin Dose High Fat Meal - Adjusted Insulin Dose +30% High Fat Meal - Adjusted Insulin Dose +Split Dose Dietary Supplement: Meal composition Drug: Rapid-Acting Insulin Dose Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
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
Experimental: 2
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
Experimental: 3
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
Experimental: 4
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



Primary Outcome Measures :
  1. Glycaemic responses. Assessed via venous blood concentrations at periodic intervals. [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Lipaemic responses. Assessed via venous blood concentrations at periodic intervals. [ Time Frame: 6 hours ]
  2. Interstitial glucose responses. Assessed using real-time continuous glucose monitoring throughout the duration of the study [ Time Frame: 24 hours ]
  3. Inflammatory responses. Assessed via venous blood concentrations at periodic intervals. [ Time Frame: 6 hours ]
    Assessed via venous blood

  4. Appetite responses. Assessed via subjective visual analogue scales at periodic intervals [ Time Frame: 6 hours ]
    Assessed via subjective visual analogue scales



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For inclusion in the study, volunteers will be -

  • 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.
Layout table for additonal information
Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT02595658    
Other Study ID Numbers: West-Walker4
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs