beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets Phase 4 120 Dietary

Unknown status
Clinical Trial NCT04562454 is designed to study Other for Diabetes. It is a Phase 4 interventional study that is unknown status, having started on 1 October 2020, with plans to enroll 120 participants. Led by Peking Union Medical College Hospital, it is expected to complete by 1 October 2021. The latest data from ClinicalTrials.gov was last updated on 24 September 2020.
Brief Summary
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients w...Show More
Detailed Description
In this study, subjects with diabetes or impaired glucose tolerance were given continuous glucose monitoring (CGM) for 3 consecutive days, given a standard meal containing 50g carbohydrates and foods to be tested for GI. The purpose of this study was to explore the fluctuation of blood glucose, the time and range of blood glucose peak after eating different diets, and to guide the individual dietary choices of the su...Show More
Official Title

An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets

Conditions
Diabetes
Other Study IDs
  • 20200920-JS-2450
NCT ID Number
NCT04562454
Start Date (Actual)
2020-10-01
Last Update Posted
2020-09-24
Completion Date (Estimated)
2021-10-01
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 4
Status
Unknown status
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNormal group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
ExperimentalT1DM group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
ExperimentalT2DM group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
Experimentalother type of diabetes group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
fluctuation of blood glucose after eating different food
use the CGM to get the area under the curve of blood glucose of different food
baseline
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. the experimental group: patients with diabetes or impaired glucose tolerance diagnosed clinically according to the World Health Organization's (WHO) diagnostic criteria of diabetes in 1999; the control group: according to the participants of the experimental group, matched the people with normal glucose metabolism in sex, age and region.
  2. Age: 18-80 years old; 3) patients or family members who can understand the research plan and are willing to participate in this study and sign a written informed consent form and questionnaire

  1. severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
  2. serious chronic complications of diabetes, such as peripheral vascular disease leading to amputation or chronic foot ulcers, end-stage renal disease, etc., the researchers do not think it is suitable to participate in this study.；
  3. patients with two or more episodes of severe hypoglycemia in the past year (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or severe unconscious hypoglycemia;
  4. patients with severe impairment or circulatory disturbance of cardiac function (NYHA grade III or above), liver function (ALT, AST or TBil above the upper limit of the normal value), renal function (serum creatinine above the upper limit of the normal value) or circulatory disturbance.；
  5. patients with mental illness, confusion and inability to take care of themselves;
  6. patients with gastrointestinal diseases;
  7. patients or their families cannot understand the conditions and objectives of this study
Peking Union Medical College Hospital logoPeking Union Medical College Hospital482 active studies to explore
Study Central Contact
Contact: Weigang Zhao, MD, +86 69151876, [email protected]
Contact: Shuoning Song, 15117977900, [email protected]
No location data.