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Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes (SWEETS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185662
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
ShiBei Hospital , JingAn District, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
PuNan Hospital ,Shanghai
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: sucralose Not Applicable

Detailed Description:
Artificial sweeteners are among the most widely used food additives worldwide. Artificial sweeteners consumption is considered safe and beneficial owing to their low caloric content. However, recent studies demonstrated that consumption of commonly used artificial sweeteners formulations drives the development of glucose intolerance in healthy human subjects. However,the effects of artificial sweeter on glucose metabolism in newly diagnosed type 2 diabetic patients remains unknown. Thus, different doses of sweeteners will be given to newly diagnosed type 2 diabetic patients to investigate the effects of artificial sweeteners on glucose metabolism.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
intake 200 ml water daily for 3 months
Dietary Supplement: sucralose
daily intake different dose of artificial sweeteners sucralose or placebo

Experimental: low dose sucrolose group
intake 12.3mg sucralose in 200 ml water daily for 3 months
Dietary Supplement: sucralose
daily intake different dose of artificial sweeteners sucralose or placebo

Experimental: moderate dose sucrolose group
intake 73.8mg sucralose in 200ml water daily for 3 months
Dietary Supplement: sucralose
daily intake different dose of artificial sweeteners sucralose or placebo




Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: 3 month ]
    Fasting glucose change from baseline

  2. postprandial blood sugar [ Time Frame: 3 month ]
    postprandial blood glucose change from baseline

  3. HbA1c [ Time Frame: 3 month ]
    HbA1c change from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with newly diagnosed type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital, Shanghai PuNan hospital,Shanghai ShiBei hospital, shanghai xinhua hospital, chongming branch;
  • FBG≤ 9 mmol/L, HbA1c≤ 7% ;without any oral hypoglycemic agents or insulin,
  • Age ≥30 and ≤ 60 years old.
  • BMI >24 and <28 kg/m2; --no regular consumption of artificial sweeteners or foods that have added much sweeteners.(eg:Coca-Cola zero), no sucralose intolerance.

Exclusion Criteria:

  • patients who had a history of acute and chronic diarrhea or constipation or severe chronic gastrointestinal disease..
  • underwent enterectomy or other abdominal surgery (e.g., gallbladder removal) within one year;
  • take antibiotics, antidiarrheic, antispasmodic, steroids and immune agents within three months.
  • Patients who had a history of abnormal renal function(creatinine >132μmol/L), active liver disease(ALT were 2.5 times higher than the normal upper limit), or accompany with other sever diseases, such as severe infection, severe anemia, neutropenia and mental illness.
  • Other serious heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated heart disease,cardiac function(NYHA) classification>level III.
  • A history of acute complications such as diabetic ketoacidosis or hypertonic coma within 3 months.
  • pregancy
  • Allergic to sweeteners.
  • participant in any clinical trail within 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185662


Contacts
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Contact: Jing Ma, professor 58752345 ext 3083 cherry1996@live.cn

Locations
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China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
ShiBei Hospital , JingAn District, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
PuNan Hospital ,Shanghai
Investigators
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Principal Investigator: Jing Ma, professor RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04185662    
Other Study ID Numbers: T2DM20190619
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by RenJi Hospital:
artificial sweetners
glucose metabolism
type 2 diabetic patients
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases