Type 2 DiabetesNCT06902077
A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
A study testing low carb diet and diabetic diet in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- low carb diet and diabetic diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 12-18
- Diabetes diagnosis >3 months to ensure stable baseline glycemic control
- HbA1C between 6.5- 8.5%
- BMI >85th percentile
- Negative pancreatic autoantibodies
- Stable dose of anti-diabetic drugs GLP-1, metformin, SGLT-2 inhibitors, for 3 months
Who cannot join
- Current insulin treatment
- Renal impairment measured as creatinine > 1 mg/dL
- Hepatic dysfunction measured as AST and ALT >100 IU/ml
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham/ Children's of Alabama
Birmingham, Alabama, 35233
Ortal Resnick, MD, 205-638-9107, oresnick@uabmc.edu
Ortal Resnick, MD
About this study
Official title: Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.
Read the detailed description
Background Type 2 diabetes (T2D) in teenagers is becoming a growing health concern. In the U.S., the number of children and teens diagnosed with T2D nearly doubled between 2002 and 2018. Experts predict that in the next 40 years, the number of young people with T2D could quadruple.
T2D in youth is different from T2D in adults. Teens with T2D have more insulin resistance and their bodies struggle to make enough insulin. Unfortunately, common diabetes medications do not stop the disease from getting worse. Better treatment options for young people with T2D are needed.
T2D happens when the body becomes resistant to insulin and the pancreas struggles to keep up. Diet is a key part of managing T2D, but there are no clear guidelines for the best diet for teens with diabetes.
In adults, low-carbohydrate diets (LCDs) have been shown to:
- Lower blood sugar and improve diabetes control
- Improve insulin function and protect the pancreas
- Reduce the need for diabetes medications
- Help with weight loss, especially in areas of harmful fat like the liver and belly
While LCDs have been well-studied in adults, there is very little research on how they affect adolescents with T2D. A few small studies suggest that reducing carbs may help teens with obesity and fatty liver disease, but we need more evidence to know for sure.
Study Objective This study will test whether a low-carbohydrate diet (LCD) can help improve blood sugar control and insulin function in adolescents with T2D. The investigators will compare it to the standard diet for diabetes care.
How the Study Works
The investigators will conduct a randomized controlled trial (RCT), meaning that participants will be randomly placed into one of two groups:
- Low-Carb Diet (LCD): 50-80 grams of carbohydrates per day
- Standard Diabetes Diet (SCD): A diet based on current guidelines
The study will last 24 weeks (6 months). Participants will keep food records and meet with a dietitian to track their progress.
What The Study Will Measure
The investigators will test whether the low-carb diet helps improve:
- Blood sugar control (measured by HbA1c)
- Insulin function and resistance (measured by an oral glucose tolerance test)
- Weight and fat loss, especially in harmful fat stores
- Triglycerides and cholesterol levels
- Need for diabetes medications
What The Study Expect to Find
The investigators believe that teens who follow a low-carb diet will have:
- Better blood sugar control
- Less insulin resistance
- More weight loss, especially from harmful fat
- Lower triglycerides and better cholesterol levels
- Less need for diabetes medications
This study will help us understand whether reducing carbs is a safe and effective way to improve diabetes in teens.
- Conditions
- Type 2 Diabetes
- Being tested
- low carb diet, diabetic diet
- Keywords
- Pediatric type 2 diabetes, Type 2 Diabetes, low carb diet, Low-Carbohydrate Dietary
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low carb dietBehavioural
diet based on low carb with max 50-80 grams of carbohydrates daily
diabetic dietBehavioural
Balanced diet based on standard of care recommendations for type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Low carb diet | Active comparator | Participants in this group will limit the amount of carbohydrates they eat each day to 50-80 grams.
This means eating fewer sugars and starches (like bread, pasta, rice, and sweets). Instead, meals will focus on protein, healthy fats, and non-starchy vegetables. Participants will track their food and meet with a dietitian to help them stick to the plan. Receives: Behavioral: low carb diet |
| Standard of care | Active comparator | Participants in this group will follow the current standard diet for managing diabetes. This includes balanced meals with carbohydrates, protein, and fats, based on regular diabetes guidelines.
Participants will track their food and meet with a dietitian to help them stay on track. Receives: Behavioral: diabetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
HbA1c levels will be measured to assess long-term glycemic control. Unit of Measure: Percent (%).
Measured: Base line, 3 months, 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR will be calculated using fasting glucose and insulin values collected at baseline. The formula used is:
HOMA-IR = (fasting insulin [μU/mL] × fasting glucose [mg/dL]) / 405. This index reflects hepatic insulin resistance.
Units of Measure: Unitless index
Measured: Base line, 3 months, 6 months
Whole Body Insulin Sensitivity Index (WBISI)
WBISI will be calculated using values from the 2-hour Oral Glucose Tolerance Test (OGTT). The formula is:
WBISI = 10,000 / √(fasting glucose × fasting insulin × mean OGTT glucose × mean OGTT insulin).
This index reflects peripheral insulin sensitivity.
Units of Measure: Unitless index
Measured: Base line, 3 months, 6 months
Secondary outcomes (4)
Change in BMI
Weight and height will be combined to report BMI. Weight in kilograms divided by height in meters squared (kg/m²). Height will be measured using a wall-mounted stadiometer.
Unit of Measure: kg/m²
Measured: Base line, 3 months, 6 months
Change in blood pressure
Systolic and diastolic blood pressure will be measured in triplicate using an automated oscillometric blood pressure monitor after the participant has been seated quietly for 5 minutes.
Measurement Tool: Automated oscillometric blood pressure monitor
Unit of Measure: Millimeters of mercury (mmHg)
Measured: Base line, 3 months, 6 months
Change in lipid profile
Fasting lipid profile will be assessed via venous blood sample. Parameters will include total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
Unit of Measure: Milligrams per deciliter (mg/dL)
Measured: Base line, 3 months, 6 months
Change in body composition
Body composition will be assessed using a validated bioelectrical impedance analysis (BIA) scale, which estimates fat mass, lean mass, and total body water.
Measurement Tool: Bioelectrical impedance analysis (BIA) scale
Unit of Measure: Percent body fat (%) and lean mass (%)
Measured: Base line, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start25 Nov 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's of Alabama
- Responsible party
- Principal investigator, Ortal Resnick, University of Alabama at Birmingham
- Investigators
- Ortal Resnick, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902077
- Sponsor's protocol ID
- IRB-300014030
- Other IDs
- 3130035.000.213130035.31165200
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06902077
- Acronym / sponsor ID
- IRB-300014030
- Conditions
- Type 2 Diabetes
- Keywords
- Pediatric type 2 diabetes, Type 2 Diabetes, low carb diet, Low-Carbohydrate Dietary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's of Alabama
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 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.
The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.
Detailed description
Background Type 2 diabetes (T2D) in teenagers is becoming a growing health concern. In the U.S., the number of children and teens diagnosed with T2D nearly doubled between 2002 and 2018. Experts predict that in the next 40 years, the number of young people with T2D could quadruple.
T2D in youth is different from T2D in adults. Teens with T2D have more insulin resistance and their bodies struggle to make enough insulin. Unfortunately, common diabetes medications do not stop the disease from getting worse. Better treatment options for young people with T2D are needed.
T2D happens when the body becomes resistant to insulin and the pancreas struggles to keep up. Diet is a key part of managing T2D, but there are no clear guidelines for the best diet for teens with diabetes.
In adults, low-carbohydrate diets (LCDs) have been shown to:
- Lower blood sugar and improve diabetes control
- Improve insulin function and protect the pancreas
- Reduce the need for diabetes medications
- Help with weight loss, especially in areas of harmful fat like the liver and belly
While LCDs have been well-studied in adults, there is very little research on how they affect adolescents with T2D. A few small studies suggest that reducing carbs may help teens with obesity and fatty liver disease, but we need more evidence to know for sure.
Study Objective This study will test whether a low-carbohydrate diet (LCD) can help improve blood sugar control and insulin function in adolescents with T2D. The investigators will compare it to the standard diet for diabetes care.
How the Study Works
The investigators will conduct a randomized controlled trial (RCT), meaning that participants will be randomly placed into one of two groups:
- Low-Carb Diet (LCD): 50-80 grams of carbohydrates per day
- Standard Diabetes Diet (SCD): A diet based on current guidelines
The study will last 24 weeks (6 months). Participants will keep food records and meet with a dietitian to track their progress.
What The Study Will Measure
The investigators will test whether the low-carb diet helps improve:
- Blood sugar control (measured by HbA1c)
- Insulin function and resistance (measured by an oral glucose tolerance test)
- Weight and fat loss, especially in harmful fat stores
- Triglycerides and cholesterol levels
- Need for diabetes medications
What The Study Expect to Find
The investigators believe that teens who follow a low-carb diet will have:
- Better blood sugar control
- Less insulin resistance
- More weight loss, especially from harmful fat
- Lower triglycerides and better cholesterol levels
- Less need for diabetes medications
This study will help us understand whether reducing carbs is a safe and effective way to improve diabetes in teens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low carb diet | Active comparator | Behavioral: low carb dietParticipants in this group will limit the amount of carbohydrates they eat each day to 50-80 grams. This means eating fewer sugars and starches (like bread, pasta, rice, and sweets). Instead, meals will focus on protein, healthy fats, and non-starchy vegetables. Participants will track their food and meet with a dietitian to help them stick to the plan. |
| Standard of care | Active comparator | Behavioral: diabetic dietParticipants in this group will follow the current standard diet for managing diabetes. This includes balanced meals with carbohydrates, protein, and fats, based on regular diabetes guidelines. Participants will track their food and meet with a dietitian to help them stay on track. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 12-18
- Diabetes diagnosis >3 months to ensure stable baseline glycemic control
- HbA1C between 6.5- 8.5%
- BMI >85th percentile
- Negative pancreatic autoantibodies
Key exclusion criteria (3 listed)
- Current insulin treatment
- Renal impairment measured as creatinine > 1 mg/dL
- Hepatic dysfunction measured as AST and ALT >100 IU/ml
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 |
|---|---|---|
| low carb dietdiet based on low carb with max 50-80 grams of carbohydrates daily | Behavioural | Low carb diet |
| diabetic dietBalanced diet based on standard of care recommendations for type 2 diabetes | Behavioural | Standard of care |
Primary outcome
Change in HbA1c
Time frame: Base line, 3 months, 6 months
HbA1c levels will be measured to assess long-term glycemic control. Unit of Measure: Percent (%).
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Base line, 3 months, 6 months
HOMA-IR will be calculated using fasting glucose and insulin values collected at baseline. The formula used is: HOMA-IR = (fasting insulin [μU/mL] × fasting glucose [mg/dL]) / 405. This index reflects hepatic insulin resistance. Units of Measure: Unitless index
Whole Body Insulin Sensitivity Index (WBISI)
Time frame: Base line, 3 months, 6 months
WBISI will be calculated using values from the 2-hour Oral Glucose Tolerance Test (OGTT). The formula is: WBISI = 10,000 / √(fasting glucose × fasting insulin × mean OGTT glucose × mean OGTT insulin). This index reflects peripheral insulin sensitivity. Units of Measure: Unitless index
4 secondary outcomes
Change in BMI
Time frame: Base line, 3 months, 6 months
Change in blood pressure
Time frame: Base line, 3 months, 6 months
Change in lipid profile
Time frame: Base line, 3 months, 6 months
Change in body composition
Time frame: Base line, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Ortal Resnick, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low carb diet and diabetic diet in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Dec 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ortal Resnick, MD (205-638-9107, oresnick@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Base line, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025.