Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02371694
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2015-02-19
Brief Title:
What is the Dose Response of Varying Meal Content of Fat on Postprandial Glycaemia in Children With T1DM
Sponsor:
Cork University Hospital
Organization:
Cork University Hospital
Study Overview
Official Title:
What is the Dose Response of Varying Meal Content of Fat on Postprandial Glycaemia in Children With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REQINSOIL
Brief Summary:
Background Based on international evidence current management of people with T1DM on intensive insulin therapy IIT use algorithms based on the meal carbohydrate content MCC to calculate the prandial insulin dose Typically these calculations do not take into account the protein or fat content of the meal There is a lack of clinical advice for optimal management of high proteinfat meals due to a paucity of evidence regarding the impact of proteinfat on glycaemic control
Objective To determine the mean glucose excursion from fasting measured by continuous glucose monitoring CGMS at each 30 minute interval over the 8 hour postprandial period for each test condition Protein effects will be looked at in a separate parallel study in Australia
Hypothesis The fat content of a meal will cause a dose-response change in the postprandial glucose concentration in children with T1DM
Research Design and Methods Randomised cross-over study involving thirty patients Inclusion criteria T1DM 1 year aged 8-18 years with HbA1c 8 and BMI 91st centile on intensive insulin therapy Participants will be given a test meal on 6 consecutive nights in random order 4 test meals varying in fat content and one 20g carbohydrate test meal with zero fat given as control meal A CGMS will be used to assess glucose responses at 5 minute intervals for 8 hours after test meal consumption The relationship between the fat loads in the test meals and the mean change in postprandial glucose concentration will be analysed and described
Conclusions This study will determine whether fat causes dose dependent response in glucose concentrations leading to refining the guidelines and possible adjustment of insulin doses for the fat content of a meal
Objective To determine the mean glucose excursion from fasting measured by continuous glucose monitoring CGMS at each 30 minute interval over the 8 hour postprandial period for each test condition Protein effects will be looked at in a separate parallel study in Australia
Hypothesis The fat content of a meal will cause a dose-response change in the postprandial glucose concentration in children with T1DM
Research Design and Methods Randomised cross-over study involving thirty patients Inclusion criteria T1DM 1 year aged 8-18 years with HbA1c 8 and BMI 91st centile on intensive insulin therapy Participants will be given a test meal on 6 consecutive nights in random order 4 test meals varying in fat content and one 20g carbohydrate test meal with zero fat given as control meal A CGMS will be used to assess glucose responses at 5 minute intervals for 8 hours after test meal consumption The relationship between the fat loads in the test meals and the mean change in postprandial glucose concentration will be analysed and described
Conclusions This study will determine whether fat causes dose dependent response in glucose concentrations leading to refining the guidelines and possible adjustment of insulin doses for the fat content of a meal
Detailed Description:
1 Aims of the project To determine the postprandial glucose dose-response curves response to varying fat amounts by studying various parameters glycaemic excursion rate of glucose level increase area under the curve percent time in target glucose range maximal glucose excursion time to maximal glucose excursion and time until the glucose level returns to fasting concentration provided by continuous glucose monitoring over a 6 day study period with a view to provide data to calculate an accurate insulin dosing schedule to account for varying dietary fat ingestion
Objective 1 To define the impact of varying quantities dose of fat on the post-prandial glucose concentrations ie determine the relationship between the fat load in the test meals and the mean change in postprandial glucose concentrations
Objective 2 To compare the impact of the varying fat quantities in the test meals each with a control carbohydrate snack 20g without extra insulin
2 Protocol Participants will be contacted daily for one week prior to the study to review their overnight and fasting glucose concentrations and if necessary adjust their insulin doses The study will be carried out during a week long period for each patient Participants will be given test meals over 6 consecutive days in random order with 5 test meals varying in lipid content and one carbohydrate 20g test meal as comparator A continuous glucose monitoring system CGMS will be inserted on the day of the first test meal and will be removed at the completion of the sixth night
To define the impact of lipid on the post-prandial glucose concentration participants will consume a standardised meal at 1800hours and receive a standard insulin bolus by injection or pump using standard wave bolus if on insulin pump based on the meal carbohydrate content At 2200 hours the participants will consume a lipid test meal dose varying fat content of 25 125 25 375 50g or carbohydrate snack 20g The calculations of the fat doses have been based on the Pankowska algorithm 3 which recommends additional insulin for every 100 kcal fat or protein There will be randomised order of test meals
Test meals will be formulated to be palatable consumed within 5 minutes and to contain negligible carbohydrate protein and fibre A dietician will design the test meals in conjunction with the co-investigator in detail to ensure ease of formulation and practical administration
The lipid dose in test meals will be tested for acceptability and palatability to ensure adherence to protocol The order of the test meal typescarbohydrate snacks will be random computer generated randomisation The comparator 20g carbohydrate snack has been included to assess the participants typical glucose response to 20g of carbohydrate No insulin will be given for the lipid or carbohydrate snacks Participants will fast until breakfast
3 Outcomes Glucose concentrations will be measured at the start of the test meal and at 5 minute intervals over the 8 hour postprandial period Therefore the data will consist of repeated measurements on the same individual within test meal loads as well as the same individuals across test meal loads
The primary outcome of interest will be the Area Under the Curve AUC of glucose concentrations during the post prandial 8 hours Linear regressions within a generalised linear mixed model framework will be used to test for a dose response in AUCs with increasing size of fat means
Objective 1 To define the impact of varying quantities dose of fat on the post-prandial glucose concentrations ie determine the relationship between the fat load in the test meals and the mean change in postprandial glucose concentrations
Objective 2 To compare the impact of the varying fat quantities in the test meals each with a control carbohydrate snack 20g without extra insulin
2 Protocol Participants will be contacted daily for one week prior to the study to review their overnight and fasting glucose concentrations and if necessary adjust their insulin doses The study will be carried out during a week long period for each patient Participants will be given test meals over 6 consecutive days in random order with 5 test meals varying in lipid content and one carbohydrate 20g test meal as comparator A continuous glucose monitoring system CGMS will be inserted on the day of the first test meal and will be removed at the completion of the sixth night
To define the impact of lipid on the post-prandial glucose concentration participants will consume a standardised meal at 1800hours and receive a standard insulin bolus by injection or pump using standard wave bolus if on insulin pump based on the meal carbohydrate content At 2200 hours the participants will consume a lipid test meal dose varying fat content of 25 125 25 375 50g or carbohydrate snack 20g The calculations of the fat doses have been based on the Pankowska algorithm 3 which recommends additional insulin for every 100 kcal fat or protein There will be randomised order of test meals
Test meals will be formulated to be palatable consumed within 5 minutes and to contain negligible carbohydrate protein and fibre A dietician will design the test meals in conjunction with the co-investigator in detail to ensure ease of formulation and practical administration
The lipid dose in test meals will be tested for acceptability and palatability to ensure adherence to protocol The order of the test meal typescarbohydrate snacks will be random computer generated randomisation The comparator 20g carbohydrate snack has been included to assess the participants typical glucose response to 20g of carbohydrate No insulin will be given for the lipid or carbohydrate snacks Participants will fast until breakfast
3 Outcomes Glucose concentrations will be measured at the start of the test meal and at 5 minute intervals over the 8 hour postprandial period Therefore the data will consist of repeated measurements on the same individual within test meal loads as well as the same individuals across test meal loads
The primary outcome of interest will be the Area Under the Curve AUC of glucose concentrations during the post prandial 8 hours Linear regressions within a generalised linear mixed model framework will be used to test for a dose response in AUCs with increasing size of fat means
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None