Type 2 Diabetes Mellitus (T2DM)NCT06936657
Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
A study testing optimized carbohydrate diet and conventional diabetes diet in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai 6th People's Hospital.
Trial summary
This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- optimized carbohydrate diet and conventional diabetes diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2025to 31 Oct 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
- HbA1c ≥ 7% and < 9%
- Antidiabetic medication has been stable for at least 3 months before recruitment
- Aged 35-70 years
- Signed the informed consent form
Who cannot join
- Treatment with insulin
- Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
- Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
- Having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (eGFR ≤60 ml/min/1.73 m²)
- Presence of cardiovascular events (e.g., myocardial infarction, stent placement, unstable angina, heart failure, cardiac dysfunction) or cerebrovascular diseases (e.g., intracerebral hemorrhage, ischemic stroke) within the past 6 months
- Diagnosis of acute or chronic gastrointestinal diseases (e.g., ulcers), hyperthyroidism or hypothyroidism, uncontrolled hypertension, active malignancy not in remission, or other life-threatening diseases
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- Recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use
- Unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids)
- Pregnancy, breastfeeding, or planning pregnancy
- Presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fMRI
- Psychiatric disorders impairing cooperation
- Expected poor compliance
- Current or recent (within 4 weeks prior to study initiation) participation in other clinical trials
About this study
This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- optimized carbohydrate diet, conventional diabetes diet
- 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.
optimized carbohydrate dietOther
In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy.
conventional diabetes dietOther
In this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy.
| Study group | Role | What they receive |
|---|---|---|
| optimized carbohydrate diet-washout-conventional diabetes diet | Experimental | Group that starts with the optimized carbohydrate diet Receives: Other: optimized carbohydrate diet; Other: conventional diabetes diet |
| conventional diabetes diet-washout-optimized carbohydrate diet | Experimental | Group that starts with the conventional diabetes diet Receives: Other: optimized carbohydrate diet; Other: conventional diabetes diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours
Average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system.
Measured: -2, 0, 10, 16, 18 and 28 weeks
Secondary outcomes (14)
Change in other parameters of Continuous Glucose Monitoring
Other parameters of Continuous Glucose Monitoring, including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Mean Glucose, Glucose Variability, Glycemic Excursions, Area Under the Curve (AUC), and other relevant metrics, will be assessed at -2, 0, 10, 16, 18, and 28 weeks.
Measured: -2, 0, 10, 16, 18 and 28 weeks
Change in HbA1c
HbA1c will be measured at baseline, 12, 18 and 30 weeks. HbA1c will be expressed in mmol/mol.
Measured: Baseline, 12, 18 and 30 weeks
Change in insulin sensitivity
Insulin sensitivity will be assessed at baseline, 12, 18 and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in other clinical biochemical indicators
Other clinical biochemical indicators will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks.
Measured: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in blood glucose
Fasting blood glucose will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. During meal tolerance test (MTT) at baseline, 12, 18 and 30 weeks, blood glucose at 0, 30, 60, 90, 120 minutes will be measured. Glucose concentration will be expressed in mmol/L
Measured: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in insulin and C peptide secretion
Fasting insulin and C peptide concentration will be assessed at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. During meal tolerance test (MTT) at baseline, 12, 18 and 30 weeks, insulin and C peptide concentration at 0, 30, 60, 90, 120 minutes will be measured. Insulin concentration will be expressed in uU/ml. C peptide concentration will be expressed in ng/ml.
Measured: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in anthropometry and body composition parameters
Anthropometry and body composition parameters will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks.
Measured: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in cognitive function and behavioral performance
Cognitive function changes will be assessed using questionnaires (including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA, Beijing version), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test, Stroop Color and Word Test, and others) at baseline, 12 18, and 30 weeks. Behavioral performance will be assessed using N-back and other paradigms at baseline, 12, 18, and 30 weeks.
In addition, subgroups within the two arms will undergo fMRI to assess cognitive function at baseline, 12 18, and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in appetite
Appetite will be measured by visual analog scales (VAS) and other relevant scales, and will be assessed at baseline, 12, 18, and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in emotion
Emotion will be measured using the PHQ-9 depression screening scale, the Problem Areas in Diabetes (PAID) questionnaire, and other relevant scales at baseline, 12, 18, and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire and other methods at baseline, 12, 18, and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in bowel habits
Bowel habits will be assessed using the Bristol Stool Form Scale (BSFS; range: 1-7, with higher scores indicating looser stools) and other relevant scales at baseline, 12, 18, and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in cardiopulmonary exercise testing performance
Cardiopulmonary exercise testing performance will be conducted at baseline, 12, 18 and 30 weeks.
Measured: Baseline, 12, 18 and 30 weeks
Change in blood lipid profiles
Blood lipid profiles will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks.
Measured: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start20 Oct 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 2 Diabetes Mellitus (T2DM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Huating, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936657
- Sponsor's protocol ID
- 2025-018
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu Y, Zhang R, Yang J, Liu D, Wu Q, Long X, Cheng D, Guo J, Li Q, Zhang Y, Kang P, Wang Q, Gao X, Zeng R, Zhang M, Fang Q, Jia W, Ni Y, Li H. Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial. BMJ Open. 2025 Oct 7;15(10):e106756. doi: 10.1136/bmjopen-2025-106756.
PubMed 41062131
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06936657
- Acronym / sponsor ID
- 2025-018
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 20 Apr 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.
This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimized carbohydrate diet-washout-conventional diabetes diet | Experimental | Other: optimized carbohydrate diet, Other: conventional diabetes dietGroup that starts with the optimized carbohydrate diet |
| conventional diabetes diet-washout-optimized carbohydrate diet | Experimental | Other: optimized carbohydrate diet, Other: conventional diabetes dietGroup that starts with the conventional diabetes diet |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
- HbA1c ≥ 7% and < 9%
- Antidiabetic medication has been stable for at least 3 months before recruitment
- Aged 35-70 years
- Signed the informed consent form
Key exclusion criteria (13 listed)
- Treatment with insulin
- Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
- Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
- Having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (eGFR ≤60 ml/min/1.73 m²)
- Presence of cardiovascular events (e.g., myocardial infarction, stent placement, unstable angina, heart failure, cardiac dysfunction) or cerebrovascular diseases (e.g., intracerebral hemorrhage, ischemic stroke) within the past 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 |
|---|---|---|
| optimized carbohydrate dietIn this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy. | Other | conventional diabetes diet-washout-optimized carbohydrate diet, optimized carbohydrate diet-washout-conventional diabetes diet |
| conventional diabetes dietIn this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy. | Other | conventional diabetes diet-washout-optimized carbohydrate diet, optimized carbohydrate diet-washout-conventional diabetes diet |
Primary outcome
Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours
Time frame: -2, 0, 10, 16, 18 and 28 weeks
Average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system.
14 secondary outcomes
Change in other parameters of Continuous Glucose Monitoring
Time frame: -2, 0, 10, 16, 18 and 28 weeks
Change in HbA1c
Time frame: Baseline, 12, 18 and 30 weeks
Change in insulin sensitivity
Time frame: Baseline, 12, 18 and 30 weeks
Change in other clinical biochemical indicators
Time frame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in blood glucose
Time frame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in insulin and C peptide secretion
Time frame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in anthropometry and body composition parameters
Time frame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
Change in cognitive function and behavioral performance
Time frame: Baseline, 12, 18 and 30 weeks
Change in appetite
Time frame: Baseline, 12, 18 and 30 weeks
Change in emotion
Time frame: Baseline, 12, 18 and 30 weeks
Change in sleep quality
Time frame: Baseline, 12, 18 and 30 weeks
Change in bowel habits
Time frame: Baseline, 12, 18 and 30 weeks
Change in cardiopulmonary exercise testing performance
Time frame: Baseline, 12, 18 and 30 weeks
Change in blood lipid profiles
Time frame: Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks
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 12 Sep 2025.
- Derived from this study: PubMed 41062131Lu Y, Zhang R, Yang J, Liu D, Wu Q, Long X, Cheng D, Guo J, Li Q, Zhang Y, Kang P, Wang Q, Gao X, Zeng R, Zhang M, Fang Q, Jia W, Ni Y, Li H. Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial. BMJ Open. 2025 Oct 7;15(10):e106756. doi: 10.1136/bmjopen-2025-106756.
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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.
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 optimized carbohydrate diet and conventional diabetes diet in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai 6th People's Hospital.
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 13 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: opening soon, as of the sponsor's last update on 12 Sep 2025. 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?
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?
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 in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours (time frame: -2, 0, 10, 16, 18 and 28 weeks). 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 NCT06936657, 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 12 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.