Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
NCT06936657, Not applicable, Not yet recruiting, Shanghai 6th People's Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes | ClinicalTrials.gov |
| NCT number | NCT06936657 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai 6th People's Hospital | ClinicalTrials.gov |
| Conditions | Type 2 Diabetes Mellitus (T2DM) | ClinicalTrials.gov |
| Interventions | optimized carbohydrate diet, conventional diabetes diet | ClinicalTrials.gov |
| First posted | 2025-04-20 | ClinicalTrials.gov |
| Last updated | 2025-09-12 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours | -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. | ClinicalTrials.gov |
| Secondary | Change in other parameters of Continuous Glucose Monitoring | -2, 0, 10, 16, 18 and 28 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in HbA1c | Baseline, 12, 18 and 30 weeks | HbA1c will be measured at baseline, 12, 18 and 30 weeks. HbA1c will be expressed in mmol/mol. | ClinicalTrials.gov |
| Secondary | Change in insulin sensitivity | Baseline, 12, 18 and 30 weeks | Insulin sensitivity will be assessed at baseline, 12, 18 and 30 weeks. | ClinicalTrials.gov |
| Secondary | Change in other clinical biochemical indicators | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks | Other clinical biochemical indicators will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | ClinicalTrials.gov |
| Secondary | Change in blood glucose | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks | 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 | ClinicalTrials.gov |
| Secondary | Change in insulin and C peptide secretion | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in anthropometry and body composition parameters | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks | Anthropometry and body composition parameters will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | ClinicalTrials.gov |
| Secondary | Change in cognitive function and behavioral performance | Baseline, 12, 18 and 30 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in appetite | Baseline, 12, 18 and 30 weeks | Appetite will be measured by visual analog scales (VAS) and other relevant scales, and will be assessed at baseline, 12, 18, and 30 weeks. | ClinicalTrials.gov |
| Secondary | Change in emotion | Baseline, 12, 18 and 30 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in sleep quality | Baseline, 12, 18 and 30 weeks | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire and other methods at baseline, 12, 18, and 30 weeks. | ClinicalTrials.gov |
| Secondary | Change in bowel habits | Baseline, 12, 18 and 30 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in cardiopulmonary exercise testing performance | Baseline, 12, 18 and 30 weeks | Cardiopulmonary exercise testing performance will be conducted at baseline, 12, 18 and 30 weeks. | ClinicalTrials.gov |
| Secondary | Change in blood lipid profiles | Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks | Blood lipid profiles will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks. | ClinicalTrials.gov |
| Other | Change in the iAUC of postprandial blood glucose over 3 hours after each meal | -2, 0, 10, 16, 18 and 28 weeks | The iAUC of postprandial blood glucose over 3 hours after each meal in patients with type 2 diabetes will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system. | ClinicalTrials.gov |
| Other | Change in hepatic fat content | Baseline, 12, 18 and 30 weeks | Hepatic fat content will be assessed by Fibroscan at baseline, 12, 18 and 30 weeks. | ClinicalTrials.gov |
| Other | Change in the levels of cytokines | Baseline, 12, 18 and 30 weeks | The levels of cytokines, including FGF21, adiponectin, A-FABP, LCN2, and others, will be assessed using Enzyme-Linked Immunosorbent Assay (ELISA) and other methods at baseline, 12, 18, and 30 weeks. | ClinicalTrials.gov |
| Other | Change in immunologic function | Baseline, 12, 18 and 30 weeks | The immunologic function will be assessed through isolation and analysis of peripheral blood mononuclear cells at baseline, 12, 18, and 30 weeks. | ClinicalTrials.gov |
| Other | Change in appetite-related hormones | Baseline, 12, 18 and 30 weeks | Concentration of appetite-related hormones (e.g., ghrelin, PYY, GLP-1 and others) will be measured at baseline, 12, 18, and 30 weeks. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41062131 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)