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

NCT04562454 | Unknown Phase 4

• 1 other identifier: 20200920-JS-2450
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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 with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). GI is currently widely used to provide guidance on food choices for people with diabetes. However, there are great differences in blood glucose response among different individuals after eating the same food, which is related to a variety of factors，including individual gastrointestinal digestion and absorption rate,islet function,insulin resistance and region. A large number of foreign studies suggest that race affects the determination of GI, but different regions of our country have different dietary culture and different ability to digest and absorb different foods. Therefore, the traditional GI reference value does not necessarily fully reflect the blood glucose response of diabetic patients after eating a food. In this study, continuous blood glucose monitoring was carried out through CGM to monitor the overall fluctuation level of blood glucose, the time to peak and the range of blood glucose fluctuation after eating specific foods, and to obtain individual GI, after eating different diets to guide the future diet.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Normal group

EXPERIMENTAL

Specific diet with CGM for 5days

Other: Specific diet

T1DM group

EXPERIMENTAL

Specific diet with CGM for 5days

Other: Specific diet

T2DM group

EXPERIMENTAL

Specific diet with CGM for 5days

Other: Specific diet

other type of diabetes group

EXPERIMENTAL

Specific diet with CGM for 5days

Other: Specific diet

Interventions

Specific diet OTHER

use a specific diet in different days with CGM to konw GI of different food in diabetes

Normal group; T1DM group; T2DM group; other type of diabetes group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
• 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.；
• 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;
• 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.；
• patients with mental illness, confusion and inability to take care of themselves;
• patients with gastrointestinal diseases;
• patients or their families cannot understand the conditions and objectives of this study

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Weigang Zhao, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weigang Zhao, MD

CONTACT

+86 69151876; xiehezhaoweigang@163.com

Shuoning Song

CONTACT

15117977900; 937546635@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share