Type 1 Diabetes MellitusT1DM-HFHPNCT07158385
Effect of High Fat High Protein Meal in Type 1 Diabetes
A study testing Standard test meal (SM), High fat high protein meal-carbohydrate counting (HFHP) and High fat high protein meal-fat counting (HFHP-a) in people with Type 1 Diabetes Mellitus and Adolescent, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Despite optimal glycemic control in individuals with type 1 diabetes, post-meal hyperglycemia remains a clinical challenge, and it has been identified as an independent risk factor for the development of long-term complications, including cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Adolescent
- What is being tested?
- Standard test meal (SM), High fat high protein meal-carbohydrate counting (HFHP) and High fat high protein meal-fat counting (HFHP-a)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 17 Feb 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- No chronic disease other than type 1 diabetes mellitus
- Receiving continuous insulin infusion pump therapy
Who cannot join
- The individual's insulin requirement is less than 0.5 IU/kg/day
- High HbA1c (>8%)
- Presence of complications (Microalbuminuria, etc.)
- Presence of a comorbidity (Celiac disease, etc.)
- New initiation of CSII treatment (<6 months)
- Living outside Ankara
- Parental and individual reluctance
- The individual refuses to donate blood during the test meals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Sivas
About this study
Official title: Impact of Dietary Protein and Fat on Postprandial Glycemic Response in Adolescents With Type 1 Diabetes and Assessment of the Management of This Response Through Insulin Regimen
Aim: Despite optimal glycemic control in individuals with type 1 diabetes, post-meal hyperglycemia remains a clinical challenge, and it has been identified as an independent risk factor for the development of long-term complications, including cardiovascular diseases. With the increasing use of continuous glucose monitoring systems, evidence has been obtained that traditional insulin dosing strategies are not sufficiently effective as the effects of meals with different macronutrient content on glycemic response are further illuminated. It is argued that relying solely on counting carbohydrates for achieving glycemic control is insufficient, and that proteins and fats can cause an increase in postprandial glycemic response. Therefore, it is necessary for Type 1 diabetics to determine insulin dosage based not only on carbohydrates, but also on the amount of fats and proteins in their meals. This study investigated the protein and fat counting in addition to carbohydrate counting on the postprandial blood glucose levels in adolescents with Type 1 diabetes and analyzed the effect of the dietary fat and protein on glucagon, glucagon-like peptide-1 (GLP-1) and free fatty acid (FFA) levels.
Methods: In this single center, randomised controlled, single-blind study with regards to insulin, 11 adolescents aged 12-18 years using continuous subcutaneous insulin infusion (CSII) were given standard meal (SM), and three test meals (HFHP: high-fat-high-protein meal using carbohydrate counting; HFHP-a: high-fat-high-protein meal using carbohydrate and fat counting; HFHP-b: high-fat-high-protein meal using carbohydrate and fat-protein counting) to compare postprandial 6 hours glucose response using continuous glucose monitoring system (CGMS). Also postprandial plasma glucagon, FFA, and GLP-1 levels were compared for 6 hours after a standard meal and a high-fat-high-protein meal.
Read the detailed description
This study is designed as a single-center, randomized, controlled, single-blind study on insulin. Eleven adolescents aged 12-18 years receiving continuous subcutaneous insulin infusion (CSII) were administered a standard meal (SM) and three test meals (HFHP: high-fat-high-protein meal using carbohydrate counting; HFHP-a: high-fat-high-protein meal using carbohydrate and fat counting; HFHP-b: high-fat-high-protein meal using carbohydrate and fat-protein counting) to compare 6-hour postprandial glucose responses using continuous glucose monitoring system (CGMS). The standard meal contained 58.6 g carbohydrate, 16.9 g protein, 14.8 g fat, while the high-fat high-protein meal contained 58.2 g carbohydrate, 32.4 g protein, 30.4 g fat. CGMS were extracted from the cases and transferred to the computer, and their analysis was performed by the researcher, taking into account the capillary blood sugar measurements in the diary. Early (0-120 min), late (120-360 min), and total (0-360 min) glycemic response for the standard and test meals were analyzed using the calculation of the "incremental area under the curve" (iAUC) method. In addition, TIR (time in range) (70-180 mg/dL) and TAR (time above range) (>180 mg/dL) values obtained at early (0-120 min), late (120-360 min) and total (0-360 min) periods during the test meals of the participants were compared. Additionally, venous blood samples taken with the inserted catheter on the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal. 6-hour postprandial plasma glucagon, FFA, and GLP-1 levels were compared after the standard meal and the high-fat-high-protein meal. Early (0-120 min), late (120-360 min), and total (0-360 min) total area under the curve (tAUC) method was used to compare glucagon, GLP-1 and free fatty acid levels.
- Conditions
- Type 1 Diabetes Mellitus, Adolescent
- Being tested
- Standard test meal (SM), High fat high protein meal-carbohydrate counting (HFHP), High fat high protein meal-fat counting (HFHP-a), High fat high protein meal-fat and protein counting (HFHP-b)
- Keywords
- Type 1 diabetes, carbohydrate counting, fat protein counting, glycemic response
- 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.
Standard test meal (SM)Other
Also called Carb counting
Participants were given a standard breakfast meal with a fat and protein content similar to their daily intake. Insulin was administered according to their individual carbohydrate-to-insulin ratio. On the test day, venous blood samples were collected from the catheter inserted for GLP-1, glucagon, and free fatty acid analysis immediately before the meal (t=0 minute) and at 30, 60, 90, 120, 240, and 360 minutes after the meal.
High fat high protein meal-carbohydrate counting (HFHP)Other
Also called Carb counting
On the high-fat, high-protein meal-carbohydrate counting test day (HFHP), participants were given a high-fat and high-protein breakfast. Insulin was administered according to the individual carbohydrate-to-insulin ratio. On the test day, venous blood samples were collected from the catheter inserted for GLP-1, glucagon, and free fatty acid analysis immediately before the meal (t=0 minute) and at 30, 60, 90, 120, 240, and 360 minutes after the meal.
High fat high protein meal-fat counting (HFHP-a)Other
Also called Carb and fat counting
On the high-fat, high-protein meal-fat-counting test day (HFHP-a), participants were given a high-fat and protein breakfast. In addition to their individual carbohydrate/insulin ratio, insulin was administered based on fat counting (1 unit for every 15 g of fat after the first 15 g of fat in the meal). In this method, the insulin dose calculated based on their individual carbohydrate/insulin ratio was delivered via insulin pump as a standard bolus, while the insulin dose calculated based on their fat count was delivered as a 4 hour extended bolus.
High fat high protein meal-fat and protein counting (HFHP-b)Other
Also called Carb and fat-protein counting
On the high-fat, high-protein meal-fat and protein counting test day (HFHP-b), participants were given a high-fat and protein breakfast. In addition to the individual carbohydrate/insulin ratio, insulin was administered according to the adapted Pankowska Algorithm (1 FPU for every 100 kcal after the first 200 kcal of the meal). In this method, the insulin dose calculated based on the individual carbohydrate/insulin ratio was delivered as a standard bolus by an insulin pump, while the insulin dose calculated based on the fat and protein count was delivered as a spread over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Clinical group | Experimental | Each participant attended all 4 test meals Receives: Other: Standard test meal (SM); Other: High fat high protein meal-carbohydrate counting (HFHP); Other: High fat high protein meal-fat counting (HFHP-a); Other: High fat high protein meal-fat and protein counting (HFHP-b) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response
Glucose response was measured using continuous glucose monitoring system (CGMS). CGMS were extracted from the cases and transferred to the computer, and their analysis was performed by the researcher, taking into account the capillary blood sugar measurements in the diary. Early (0-120 min), late (120-360 min), and total (0-360 min) glycemic response for the standard and test meals were analyzed using the calculation of the "incremental area under the curve" (iAUC) method. In addition, TIR (time in range) (70-180 mg/dL) and TAR (time above range) (>180 mg/dL) values obtained at early (0-120 min), late (120-360 min) and total (0-360 min) periods during the test meals of the participants were compared.
Measured: For each intervention meal (4 interventions), participants' glucose response was assessed for 6 hours after the meals.
Plasma GLP-1 measurement
Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the GLP-1 levels.
Measured: On the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.
Plasma glucagon measurement
Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the glucagon levels.
Measured: Venous blood samples taken with the inserted catheter on the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.
Plasma free fatty acid measurement
Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the free fatty acid levels.
Measured: On the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jan 2019
- Primary completion30 Oct 2019
- Study completion17 Feb 2021
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Four different interventions were applied to the same individuals
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Nurcan Bağlam, Cumhuriyet University
- Investigators
- Zeynep Alev Özön, MD, Prof., Study chair, Hacettepe UniversityHülya Gökmen Özel, Prof. Dr., Study director, Hacettepe UniversityElmas Nazlı Gönç, MD, Prof., Principal investigator, Hacettepe UniversityAyfer Alikaşifoğlu, MD, Prof., Principal investigator, Hacettepe UniversityOytun Portakal, Assoc. Prof. Dr., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158385
- Sponsor's protocol ID
- 17-AKD-195
- Acronym
- T1DM-HFHP
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smart CE, Evans M, O'Connell SM, McElduff P, Lopez PE, Jones TW, Davis EA, King BR. Both dietary protein and fat increase postprandial glucose excursions in children with type 1 diabetes, and the effect is additive. Diabetes Care. 2013 Dec;36(12):3897-902. doi: 10.2337/dc13-1195. Epub 2013 Oct 29.
PubMed 24170749
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Protein and Fat on Postprandial Glycemic Response in Adolescents With Type 1 Diabetes and Assessment of the Management of This Response Through Insulin Regimen
- ClinicalTrials.gov ID
- NCT07158385
- Acronym / sponsor ID
- T1DM-HFHP / 17-AKD-195
- Conditions
- Type 1 Diabetes Mellitus, Adolescent
- Keywords
- Type 1 diabetes, carbohydrate counting, fat protein counting, glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 5 Sep 2025 (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.
Aim: Despite optimal glycemic control in individuals with type 1 diabetes, post-meal hyperglycemia remains a clinical challenge, and it has been identified as an independent risk factor for the development of long-term complications, including cardiovascular diseases. With the increasing use of continuous glucose monitoring systems, evidence has been obtained that traditional insulin dosing strategies are not sufficiently effective as the effects of meals with different macronutrient content on glycemic response are further illuminated. It is argued that relying solely on counting carbohydrates for achieving glycemic control is insufficient, and that proteins and fats can cause an increase in postprandial glycemic response. Therefore, it is necessary for Type 1 diabetics to determine insulin dosage based not only on carbohydrates, but also on the amount of fats and proteins in their meals. This study investigated the protein and fat counting in addition to carbohydrate counting on the postprandial blood glucose levels in adolescents with Type 1 diabetes and analyzed the effect of the dietary fat and protein on glucagon, glucagon-like peptide-1 (GLP-1) and free fatty acid (FFA) levels.
Methods: In this single center, randomised controlled, single-blind study with regards to insulin, 11 adolescents aged 12-18 years using continuous subcutaneous insulin infusion (CSII) were given standard meal (SM), and three test meals (HFHP: high-fat-high-protein meal using carbohydrate counting; HFHP-a: high-fat-high-protein meal using carbohydrate and fat counting; HFHP-b: high-fat-high-protein meal using carbohydrate and fat-protein counting) to compare postprandial 6 hours glucose response using continuous glucose monitoring system (CGMS). Also postprandial plasma glucagon, FFA, and GLP-1 levels were compared for 6 hours after a standard meal and a high-fat-high-protein meal.
Detailed description
This study is designed as a single-center, randomized, controlled, single-blind study on insulin. Eleven adolescents aged 12-18 years receiving continuous subcutaneous insulin infusion (CSII) were administered a standard meal (SM) and three test meals (HFHP: high-fat-high-protein meal using carbohydrate counting; HFHP-a: high-fat-high-protein meal using carbohydrate and fat counting; HFHP-b: high-fat-high-protein meal using carbohydrate and fat-protein counting) to compare 6-hour postprandial glucose responses using continuous glucose monitoring system (CGMS). The standard meal contained 58.6 g carbohydrate, 16.9 g protein, 14.8 g fat, while the high-fat high-protein meal contained 58.2 g carbohydrate, 32.4 g protein, 30.4 g fat. CGMS were extracted from the cases and transferred to the computer, and their analysis was performed by the researcher, taking into account the capillary blood sugar measurements in the diary. Early (0-120 min), late (120-360 min), and total (0-360 min) glycemic response for the standard and test meals were analyzed using the calculation of the "incremental area under the curve" (iAUC) method. In addition, TIR (time in range) (70-180 mg/dL) and TAR (time above range) (>180 mg/dL) values obtained at early (0-120 min), late (120-360 min) and total (0-360 min) periods during the test meals of the participants were compared. Additionally, venous blood samples taken with the inserted catheter on the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal. 6-hour postprandial plasma glucagon, FFA, and GLP-1 levels were compared after the standard meal and the high-fat-high-protein meal. Early (0-120 min), late (120-360 min), and total (0-360 min) total area under the curve (tAUC) method was used to compare glucagon, GLP-1 and free fatty acid levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Four different interventions were applied to the same individuals
| Arm | Type | Receives |
|---|---|---|
| Clinical group | Experimental | Other: Standard test meal (SM), Other: High fat high protein meal-carbohydrate counting (HFHP), Other: High fat high protein meal-fat counting (HFHP-a), Other: High fat high protein meal-fat and protein counting (HFHP-b)Each participant attended all 4 test meals |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- No chronic disease other than type 1 diabetes mellitus
- Receiving continuous insulin infusion pump therapy
Key exclusion criteria (8 listed)
- The individual's insulin requirement is less than 0.5 IU/kg/day
- High HbA1c (>8%)
- Presence of complications (Microalbuminuria, etc.)
- Presence of a comorbidity (Celiac disease, etc.)
- New initiation of CSII treatment (<6 months)
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 |
|---|---|---|
| Standard test meal (SM)Also: Carb countingParticipants were given a standard breakfast meal with a fat and protein content similar to their daily intake. Insulin was administered according to their individual carbohydrate-to-insulin ratio. On the test day, venous blood samples were collected from the catheter inserted for GLP-1, glucagon, and free fatty acid analysis immediately before the meal (t=0 minute) and at 30, 60, 90, 120, 240, and 360 minutes after the meal. | Other | Clinical group |
| High fat high protein meal-carbohydrate counting (HFHP)Also: Carb countingOn the high-fat, high-protein meal-carbohydrate counting test day (HFHP), participants were given a high-fat and high-protein breakfast. Insulin was administered according to the individual carbohydrate-to-insulin ratio. On the test day, venous blood samples were collected from the catheter inserted for GLP-1, glucagon, and free fatty acid analysis immediately before the meal (t=0 minute) and at 30, 60, 90, 120, 240, and 360 minutes after the meal. | Other | Clinical group |
| High fat high protein meal-fat counting (HFHP-a)Also: Carb and fat countingOn the high-fat, high-protein meal-fat-counting test day (HFHP-a), participants were given a high-fat and protein breakfast. In addition to their individual carbohydrate/insulin ratio, insulin was administered based on fat counting (1 unit for every 15 g of fat after the first 15 g of fat in the meal). In this method, the insulin dose calculated based on their individual carbohydrate/insulin ratio was delivered via insulin pump as a standard bolus, while the insulin dose calculated based on their fat count was delivered as a 4 hour extended bolus. | Other | Clinical group |
| High fat high protein meal-fat and protein counting (HFHP-b)Also: Carb and fat-protein countingOn the high-fat, high-protein meal-fat and protein counting test day (HFHP-b), participants were given a high-fat and protein breakfast. In addition to the individual carbohydrate/insulin ratio, insulin was administered according to the adapted Pankowska Algorithm (1 FPU for every 100 kcal after the first 200 kcal of the meal). In this method, the insulin dose calculated based on the individual carbohydrate/insulin ratio was delivered as a standard bolus by an insulin pump, while the insulin dose calculated based on the fat and protein count was delivered as a spread over 4 hours. | Other | Clinical group |
Primary outcome
Glucose response
Time frame: For each intervention meal (4 interventions), participants' glucose response was assessed for 6 hours after the meals.
Glucose response was measured using continuous glucose monitoring system (CGMS). CGMS were extracted from the cases and transferred to the computer, and their analysis was performed by the researcher, taking into account the capillary blood sugar measurements in the diary. Early (0-120 min), late (120-360 min), and total (0-360 min) glycemic response for the standard and test meals were analyzed using the calculation of the "incremental area under the curve" (iAUC) method. In addition, TIR (time in range) (70-180 mg/dL) and TAR (time above range) (>180 mg/dL) values obtained at early (0-120 min), late (120-360 min) and total (0-360 min) periods during the test meals of the participants were compared.
Plasma GLP-1 measurement
Time frame: On the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.
Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the GLP-1 levels.
Plasma glucagon measurement
Time frame: Venous blood samples taken with the inserted catheter on the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.
Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the glucagon levels.
Plasma free fatty acid measurement
Time frame: On the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.
Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the free fatty acid levels.
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 5 Sep 2025.
- Results publication: PubMed 24170749Smart CE, Evans M, O'Connell SM, McElduff P, Lopez PE, Jones TW, Davis EA, King BR. Both dietary protein and fat increase postprandial glucose excursions in children with type 1 diabetes, and the effect is additive. Diabetes Care. 2013 Dec;36(12):3897-902. doi: 10.2337/dc13-1195. Epub 2013 Oct 29.
- 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.
Zeynep Alev Özön, MD, Prof. study chair
Hacettepe University
Hülya Gökmen Özel, Prof. Dr. study director
Hacettepe University
Elmas Nazlı Gönç, MD, Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard test meal (SM), High fat high protein meal-carbohydrate counting (HFHP) and High fat high protein meal-fat counting (HFHP-a) in people with Type 1 Diabetes Mellitus and Adolescent, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 2 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Glucose response (time frame: For each intervention meal (4 interventions), participants' glucose response was assessed for 6 hours after the meals.). The study lists 4 primary outcomes in all. 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 NCT07158385, 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 5 Sep 2025.