Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities (2024)

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    Original Investigation

    June3, 2024

    HangyuJi,MD1; XuefeiZhao,BS2; XinyanChen,MD3; et al HuiFang,MD4; HuailinGao,MD5; GengWei,MD6; MinZhang,MD7; HongyuKuang,MD8; BaijingYang,MD9; XiaojunCai,MD10; YanjinSu,MD11; ChunliPiao,MD12; ShuyuZhao,MD13; LiyangLi,MM14; WenliangSun,MD15; TianshuXu,MD16; QinghuaXu,MD17; YuanFan,PhD18; JianhuaYe,MB19; ChenYao,PhD20; MeixiaShang,PhD20; GuangyaoSong,MD21; LimingChen,MD22; QingshanZheng,PhD23; XinhuaXiao,MD24; LiYan,MD25; FengmeiLian,MD1; XiaolinTong,MD26; ZhenhuaJia,MD5,27; for the FOCUS Trial Committees and Investigators

    Author Affiliations Article Information

    • 1Good Clinical Practice Office, Guang’anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China

    • 2Department of Endocrinology, Guang’anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China

    • 3Department of Prevention and Treatment of Disease, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China

    • 4Department of Endocrinology, Tangshan Gongren Hospital, Tangshan, China

    • 5Department of Endocrinology, Hebei Yiling Hospital, Shijiazhuang, China

    • 6Department of Traditional Chinese Medicine, Shijiazhuang 2nd Hospital, Shijiazhuang, China

    • 7Department of General Practice, Baotou Central Hospital, Baotou, China

    • 8Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China

    • 9Department of Traditional Chinese Medicine, The First Affiliated Hospital of Medical College of Shihezi University, Shihezi, China

    • 10Department of Endocrinology, Heilongjiang Academy of Traditional Chinese Medicine, Harbin, China

    • 11Department of Endocrinology, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Xianyang, China

    • 12Department of Endocrinology, Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine, Shenzhen, China

    • 13Department of Endocrinology, Tongliao City Horqin District First People’s Hospital, Tongliao, China

    • 14Department of Endocrinology, Baoji Second People’s Hospital, Baoji, China

    • 15Department of Endocrinology, Hebei Cangzhou Hospital of Integrated Chinese and Western Medicine, Cangzhou, China

    • 16Department of Traditional Chinese Medicine, Nanjing Drum Tower Hospital, Nanjing, China

    • 17Geriatrics Department, Liaocheng People’s Hospital, Liaocheng, China

    • 18Department of Endocrinology, Second Affiliated Hospital of Yunnan University of Chinese Medicine, Kunming, China

    • 19Department of Endocrinology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China

    • 20Department of Biostatistics, Peking University First Hospital, Beijing, China

    • 21Department of Endocrinology, Hebei General Hospital, Shijiazhuang, China

    • 22NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China

    • 23Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China

    • 24Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China

    • 25Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yai-Sen University, Guangzhou, China

    • 26Metabolic Disease Institute, Guang’anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China

    • 27State Key Laboratory for Innovation and Transformation of Luobing Theory of Hebei Yiling Hospital, Shijiazhuang, Hebei Province, China

    JAMA Intern Med. Published online June 3, 2024. doi:10.1001/jamainternmed.2024.1190

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    Visual Abstract.Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities

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    • Editor's Note Traditional Chinese Medicine to Prevent Type 2 Diabetes—A Difficult Path Forward

      Mitchell H.Katz,MD

      JAMA Internal Medicine

    Full Text

    Key Points

    Question Can long-term use of Jinlida granules (JLD) reduce the incidence of diabetes in participants with impaired glucose tolerance (IGT) and multiple metabolic abnormalities?

    Findings In this randomized clinical trial of 889 participants with IGT and multiple metabolic abnormalities, after a median follow-up of 2.20 years, the JLD group had a significantly lower risk of developing diabetes compared with the placebo group.

    Meaning In participants with IGT combined with multiple metabolic disorders, JLD reduced the incidence of diabetes compared with placebo.

    Abstract

    Importance Previous studies have shown that Jinlida (JLD) granules, an approved treatment for type 2 diabetes in China, can reduce blood glucose level, reduce glycated hemoglobin (HbA1c), and improve insulin resistance in people with type 2 diabetes.

    Objective To evaluate the effect of long-term administration of JLD vs placebo on the incidence of diabetes in participants with impaired glucose tolerance (IGT) and multiple metabolic abnormalities.

    Design, Setting, and Participants This multicenter, double-blind, placebo-controlled randomized clinical trial (FOCUS) was conducted across 35 centers in 21 cities in China from June 2019 to February 2023. Individuals aged 18 to 70 years with IGT and multiple metabolic abnormalities were enrolled.

    Intervention Participants were randomly allocated 1:1 to receive JLD or placebo (9 g, 3 times per day, orally). They continued this regimen until they developed diabetes, withdrew from the study, were lost to follow-up, or died.

    Main Outcomes and Measures The primary outcome was the occurrence of diabetes, which was determined by 2 consecutive oral glucose tolerance tests. Secondary outcomes included waist circumference; fasting and 2-hour postprandial plasma glucose levels; HbA1c; fasting insulin level; homeostatic model assessment for insulin resistance (HOMA-IR); total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels; ankle-brachial index; and carotid intima-media thickness.

    Results A total of 889 participants were randomized, of whom 885 were in the full analysis set (442 in the JLD group; 443 in the placebo group; mean [SD] age, 52.57 [10.33] years; 463 [52.32%] female). Following a median observation period of 2.20 years (IQR, 1.27-2.64 years), participants in the JLD group had a lower risk of developing diabetes compared with those in the placebo group (hazard ratio, 0.59; 95% CI, 0.46-0.74; P < .001). During the follow-up period, the JLD group had a between-group difference of 0.95 cm (95% CI, 0.36-1.55 cm) in waist circumference, 9.2 mg/dL (95% CI, 5.4-13.0 mg/dL) in 2-hour postprandial blood glucose level, 3.8 mg/dL (95% CI, 2.2-5.6 mg/dL) in fasting blood glucose level, 0.20% (95% CI, 0.13%-0.27%) in HbA1c, 6.6 mg/dL (95% CI, 1.9-11.2) in total cholesterol level, 4.3 mg/dL (95% CI, 0.8-7.7 mg/dL) in low-density lipoprotein cholesterol level, 25.7 mg/dL (95% CI, 15.9-35.4 mg/dL) in triglyceride levels, and 0.47 (95% CI, 0.12-0.83) in HOMA-IR compared with the placebo group. After 24 months of follow-up, the JLD group had a significant improvement in ankle-brachial index and waist circumference compared with the placebo group.

    Conclusions and Relevance The findings suggest that JLD can reduce the risk of diabetes in participants with IGT and multiple metabolic abnormalities.

    Trial Registration Chinese Clinical Trial Register: ChiCTR1900023241

    • Editor's Note Traditional Chinese Medicine to Prevent Type 2 Diabetes—A Difficult Path Forward

      JAMA Internal Medicine

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    Ji H, Zhao X, Chen X, et al. Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: The FOCUS Randomized Clinical Trial. JAMA Intern Med. Published online June 03, 2024. doi:10.1001/jamainternmed.2024.1190

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        Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities (2024)

        FAQs

        How to fix impaired glucose tolerance? ›

        Specifically, consuming a healthy diet (high in polyunsaturated fatty acids, monounsaturated fatty acids, fiber, and whole grains), losing weight, quitting smoking, consuming alcohol in moderation, and increasing physical activity can improve glucose tolerance and reduce the risk of T2D.

        What to eat with impaired glucose intolerance? ›

        Try to divide your plate into some starchy carbohydrate foods, vegetables and lean meat, fish, beans or alternatives. Oily fish contains a type of fat called omega 3, which helps protect against heart disease. You should try to have oily fish in your diet at least once a week.

        How to improve glucose tolerance test results? ›

        There's no way to guarantee you'll pass the glucose screening test, but you're more likely to get a good result if you first eat a light breakfast that's high in protein and low in sugar, then take a quick walk.

        How is impaired glucose tolerance treated in pregnancy? ›

        Insulin therapy and blood glucose monitoring

        Insulin can either be given as intermediate-acting insulin or as a mixture of short- and intermediate-acting insulin twice daily. Multiple daily injections are only rarely needed. Insulin treat- ment should be discontinued after delivery.

        What helps lower blood glucose levels back to normal? ›

        Exercise is good for your health and can help lower your blood sugar. It's recommended you do at least 150 minutes of moderate exercise or 75 minutes of vigorous exercise each week. You can split this up into small amounts throughout the week. Aim for a full body strength training routine two times per week.

        How to lower fasting blood sugar? ›

        High fasting blood sugar in the morning is not uncommon, even among people with well-controlled diabetes. You can better avoid this by making some healthy lifestyle changes, like exercising routinely, limiting your nighttime carbs, avoiding saturated fats, getting plenty of sleep, and keeping to your treatment plan.

        What can I eat that won't raise my glucose? ›

        Foods with little impact
        • Carrots. These are considered non-starchy (as are string beans, tomatoes, mushrooms, peppers, broccoli, asparagus and cauliflower) and good in a diabetes diet.
        • High-fiber grains. ...
        • Bran cereal. ...
        • Potatoes. ...
        • Cottage cheese. ...
        • Lentils. ...
        • Strawberries and raspberries.
        May 3, 2023

        What's the best thing to eat to lower glucose? ›

        Eating protein — from meat and fish, tofu, nuts, eggs, and cheese — with carbs can slow that flow of glucose and help stabilize blood sugar. “Proteins hold back the sugars, slow them down, and then release them into the bloodstream slowly so that your blood sugar stays in a more normal range,” O'Meara says.

        What not to eat with impaired fasting glucose? ›

        Avoiding excessive intake of added sugars by limiting sugary beverages, cakes, cookies, candy and snacks. Limiting portion sizes of refined carbohydrate foods such as white bread, white rice and white pasta.

        Does drinking water help with glucose tolerance test? ›

        The blood test measures how the glucose solution was processed by your body. You can't eat or drink anything from the time you drink glucola until after your blood draw. Having a few sips of water is usually OK. A higher-than-normal blood glucose level after 60 minutes doesn't mean you have gestational diabetes.

        What not to eat the day before blood work? ›

        Eat less greasy and fried food and do not drink alcohol 1-2 days prior to the test. If you have a party the night before the test, it is better to delay the test by 1-2 days.

        What not to eat the night before a glucose test? ›

        Processed foods and foods high in refined carbohydrates and sugars should not be eaten before your gestational diabetes test.

        Can you reverse impaired glucose tolerance? ›

        If your blood sugar results are between 140 and 199 mg/dL at the 2-hour mark, you most likely have impaired glucose tolerance. IGT is reversible with diet and exercise. Along with other risk factors for type 2 diabetes, your healthcare team may want to recheck your glucose levels every few months.

        What happens when you have impaired glucose tolerance? ›

        Living with impaired glucose tolerance (IGT) means living with an increased risk of developing diabetes mellitus type 2 (T2DM) and is preceded by a long period without symptoms, which is why IGT often remains undetected for a long period of time [1, 2].

        How do you treat impaired glucose tolerance test? ›

        When the diagnosis of impaired glucose tolerance or impaired fasting glucose is made, physicians should counsel patients to lose 5 to 7 percent of their body weight and engage in moderate physical activity for at least 150 minutes per week.

        Is impaired glucose tolerance reversible? ›

        Can impaired glucose tolerance be reversed? Yes. Increasing physical activity levels and making dietary changes such as eating fewer processed and sugary foods can reduce blood sugar levels and reverse impaired glucose tolerance, or prediabetes.

        Can you improve glucose intolerance? ›

        Lifestyle modifications which improve insulin sensitivity and beta cell function are very important in the management of glucose intolerance. Several studies have shown that lifestyle intervention can reduce conversion to type 2 diabetes.

        How do you restore glucose sensitivity? ›

        Top Natural Ways to Improve Your Insulin Sensitivity
        • Get more sleep. Several studies link not getting enough sleep to reduced insulin sensitivity. ...
        • Exercise more. Regular physical activity, such as exercising, helps move sugar into the muscles for storage. ...
        • Reduce stress. ...
        • Lose a few pounds. ...
        • Eat health-promoting foods.

        What is the best drug for impaired glucose tolerance? ›

        Metformin (Glucophage, Glucophage XR, Fortamet, Glumetza, Riomet) Metformin reduces insulin resistance (ie, metformin is an insulin sensitizer). Hepatic glucose output is decreased; peripheral insulin-stimulated uptake is increased.

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