Type 1 Diabetes MellitusNCT03333525
Does Protein and Fat Content of Meal Increase Glucose Concentrations
A study testing Calculation of insulin dosages for different meals in people with Type 1 Diabetes Mellitus, run by TC Erciyes University.
Trial summary
The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Calculation of insulin dosages for different meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2013to 20 Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects:
- had Type1 Diabetes for at least 1 years;
- use multiple dose (basal-bolus) insulin therapy;
- use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
- daily inslin dose ≥0.5 IU/kg/day.
Who cannot join
- Subjects:
- had any restrictive food intake disorders (eg celiac disease or food allergy);
- had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
- diagnosed for <1 year;
- were using corticosteroid or any medication that could effect gastric emptying;
- did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
- had overweight or obese (BMI z score: ≥ 1SD and ≥ 2SD respectively);
- had not on follicular or peri-ovulatory phases of their menstrual cycles (for females).
About this study
Official title: Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial
The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.
Read the detailed description
In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Calculation of insulin dosages for different meals
- Keywords
- Fat-protein counting, Type 1 diabetes, Postprandial glucose level
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculation of insulin dosages for different mealsOther
Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.
| Study group | Role | What they receive |
|---|---|---|
| Insulin dose-CARB counting HPM group | Experimental | HPM (high protein meal), contained 36 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. Receives: Other: Calculation of insulin dosages for different meals |
| Insulin dose-CARB counting HPFM group | Experimental | HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. Receives: Other: Calculation of insulin dosages for different meals |
| Insulin dose-CARB+FPU counting-HPFM | Experimental | HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting plus fat-protein counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. Receives: Other: Calculation of insulin dosages for different meals |
| Insulin dose-CARB counting SM group | Active comparator | SM (standart meal), contained 24 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. Receives: Other: Calculation of insulin dosages for different meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Postprandial Glucose Concentrations
Change from baseline capillary blood glucose values at 240 min after control and test meals consumption.
Measured: 0-240 minutes
Secondary outcomes (1)
Postprandial insulin need
Insulin dosage was calculated by FPU (is defined as 100 calories of fat and protein) for HFPM-b meal.
Measured: [Time Frame: 0-240 minutes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start10 Sep 2013
- Primary completion20 Feb 2014
- Study completion20 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Neşe Kaya, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333525
- Sponsor's protocol ID
- 2013/173
- Other IDs
- KEPAN, ESPEN Travel Grant (36 th)
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Kaya N, Kurtoglu S, Gokmen Ozel H. Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial. J Hum Nutr Diet. 2020 Jun;33(3):396-403. doi: 10.1111/jhn.12711. Epub 2019 Oct 24.
PubMed 31647139
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03333525
- Acronym / sponsor ID
- 2013/173
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Fat-protein counting, Type 1 diabetes, Postprandial glucose level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 10 Sep 2013 (actual)
- Primary completion
- 20 Feb 2014 (actual)
- Study completion
- 20 Feb 2014 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.
Detailed description
In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Insulin dose-CARB counting HPM group | Experimental | Other: Calculation of insulin dosages for different mealsHPM (high protein meal), contained 36 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. |
| Insulin dose-CARB counting HPFM group | Experimental | Other: Calculation of insulin dosages for different mealsHPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. |
| Insulin dose-CARB+FPU counting-HPFM | Experimental | Other: Calculation of insulin dosages for different mealsHPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting plus fat-protein counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. |
| Insulin dose-CARB counting SM group | Active comparator | Other: Calculation of insulin dosages for different mealsSM (standart meal), contained 24 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- had Type1 Diabetes for at least 1 years;
- use multiple dose (basal-bolus) insulin therapy;
- use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
- daily inslin dose ≥0.5 IU/kg/day.
Key exclusion criteria (8 listed)
- had any restrictive food intake disorders (eg celiac disease or food allergy);
- had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
- diagnosed for <1 year;
- were using corticosteroid or any medication that could effect gastric emptying;
- did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calculation of insulin dosages for different mealsCalculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses. | Other | Insulin dose-CARB counting HPFM group, Insulin dose-CARB counting HPM group, Insulin dose-CARB counting SM group, Insulin dose-CARB+FPU counting-HPFM |
Primary outcome
Change Postprandial Glucose Concentrations
Time frame: 0-240 minutes
Change from baseline capillary blood glucose values at 240 min after control and test meals consumption.
1 secondary outcome
Postprandial insulin need
Time frame: [Time Frame: 0-240 minutes]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 31647139Kaya N, Kurtoglu S, Gokmen Ozel H. Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial. J Hum Nutr Diet. 2020 Jun;33(3):396-403. doi: 10.1111/jhn.12711. Epub 2019 Oct 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Calculation of insulin dosages for different meals in people with Type 1 Diabetes Mellitus, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Postprandial Glucose Concentrations (time frame: 0-240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03333525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.