The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial
Background and Aim. Studies have shown an increasing number of type 2 diabetes (T2D) patients with concomitant obesity and hyperlipidemia syndromes, resulting from relevant metabolic disorders. However, there are few medications and therapies, which can thoroughly address these issues. Therefore, th...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2018-01-01
|
| Series: | International Journal of Endocrinology |
| Online Access: | http://dx.doi.org/10.1155/2018/9519231 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832567672449007616 |
|---|---|
| author | Xiaotong Yu Lipeng Xu Qiang Zhou Shengping Wu Jiaxing Tian Chunli Piao Hailong Guo Jun Zhang Liping Li Shentao Wu Meizhen Guo Yuzhi Hong Weirong Pu Xiyan Zhao Yang Liu Bing Pang Zhiping Peng Song Wang Fengmei Lian Xiaolin Tong |
| author_facet | Xiaotong Yu Lipeng Xu Qiang Zhou Shengping Wu Jiaxing Tian Chunli Piao Hailong Guo Jun Zhang Liping Li Shentao Wu Meizhen Guo Yuzhi Hong Weirong Pu Xiyan Zhao Yang Liu Bing Pang Zhiping Peng Song Wang Fengmei Lian Xiaolin Tong |
| author_sort | Xiaotong Yu |
| collection | DOAJ |
| description | Background and Aim. Studies have shown an increasing number of type 2 diabetes (T2D) patients with concomitant obesity and hyperlipidemia syndromes, resulting from relevant metabolic disorders. However, there are few medications and therapies, which can thoroughly address these issues. Therefore, the current study evaluated the efficacy and safety of using JTTZ, a Chinese herbal formula, to treat T2D with obesity and hyperlipidemia. Methods. A total of 450 participants with T2D (HbA1c ≥ 7.0%; waist circumference ≥ 90 cm and 80 cm in males and females, resp.; and triglycerides (TG) ≥ 1.7 mmol/L) were randomly assigned, in equal proportions, to two groups in this multicenter randomized, positive-controlled, open-label trial. One group received JTTZ formula, and the other received metformin (MET) for 12 consecutive weeks. The primary efficacy outcomes were changes in HbA1c, TG, weight, and waist circumference. Adverse reactions and hypoglycemia were monitored. Results. HbA1c decreased by 0.75 ± 1.32% and 0.71 ± 1.2% in the JTTZ and MET groups, respectively, after 12 weeks of treatment. TG levels in the JTTZ and MET groups were reduced by 0.64 ± 2.37 mmol/L and 0.37 ± 2.18 mmol/L, respectively. Weight was decreased by 2.47 ± 2.71 kg in the JTTZ group and by 2.03 ± 2.36 kg in the MET group. JTTZ also appeared to alleviate insulin resistance and increase HOMA-β. In addition, symptoms were significantly relieved in participants in the JTTZ group compared to those in the MET group. One case of hypoglycemia was reported in the MET group. No severe adverse events were reported in either group. Conclusions. The JTTZ formula led to safe and significant improvements in the blood glucose, blood lipids, and weight levels; relieved symptoms; and enhanced β cell function for T2D patients with obesity and hyperlipidemia. The JTTZ formula has shown that it could potentially be developed as an alternative medicine for patients with T2D, particularly those who cannot tolerate metformin or other hypoglycemic drugs. This trial was registered with Clinicaltrials.gov NCT01471275. |
| format | Article |
| id | doaj-art-a9c90e9261144af3ababb42eac20d808 |
| institution | Kabale University |
| issn | 1687-8337 1687-8345 |
| language | English |
| publishDate | 2018-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Endocrinology |
| spelling | doaj-art-a9c90e9261144af3ababb42eac20d8082025-02-03T01:00:49ZengWileyInternational Journal of Endocrinology1687-83371687-83452018-01-01201810.1155/2018/95192319519231The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical TrialXiaotong Yu0Lipeng Xu1Qiang Zhou2Shengping Wu3Jiaxing Tian4Chunli Piao5Hailong Guo6Jun Zhang7Liping Li8Shentao Wu9Meizhen Guo10Yuzhi Hong11Weirong Pu12Xiyan Zhao13Yang Liu14Bing Pang15Zhiping Peng16Song Wang17Fengmei Lian18Xiaolin Tong19Graduate School, Beijing University of Chinese Medicine, Beijing 100029, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaAffiliated Hospital of Changchun University of TCM, Changchun, Jilin 130021, ChinaTianjin Dagang Hospital, Tianjin 300270, ChinaYichang Yiling Hospital, Hubei 443100, ChinaBaoding Hospital of TCM, Baoding, Hebei 071000, ChinaFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, ChinaShe County Hospital, Handan, Hebei 056400, ChinaHangzhou Hospital of TCM, Hangzhou, Zhejiang 310007, ChinaQinghai Hospital of TCM, Xining, Qinghai 810000, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, ChinaBackground and Aim. Studies have shown an increasing number of type 2 diabetes (T2D) patients with concomitant obesity and hyperlipidemia syndromes, resulting from relevant metabolic disorders. However, there are few medications and therapies, which can thoroughly address these issues. Therefore, the current study evaluated the efficacy and safety of using JTTZ, a Chinese herbal formula, to treat T2D with obesity and hyperlipidemia. Methods. A total of 450 participants with T2D (HbA1c ≥ 7.0%; waist circumference ≥ 90 cm and 80 cm in males and females, resp.; and triglycerides (TG) ≥ 1.7 mmol/L) were randomly assigned, in equal proportions, to two groups in this multicenter randomized, positive-controlled, open-label trial. One group received JTTZ formula, and the other received metformin (MET) for 12 consecutive weeks. The primary efficacy outcomes were changes in HbA1c, TG, weight, and waist circumference. Adverse reactions and hypoglycemia were monitored. Results. HbA1c decreased by 0.75 ± 1.32% and 0.71 ± 1.2% in the JTTZ and MET groups, respectively, after 12 weeks of treatment. TG levels in the JTTZ and MET groups were reduced by 0.64 ± 2.37 mmol/L and 0.37 ± 2.18 mmol/L, respectively. Weight was decreased by 2.47 ± 2.71 kg in the JTTZ group and by 2.03 ± 2.36 kg in the MET group. JTTZ also appeared to alleviate insulin resistance and increase HOMA-β. In addition, symptoms were significantly relieved in participants in the JTTZ group compared to those in the MET group. One case of hypoglycemia was reported in the MET group. No severe adverse events were reported in either group. Conclusions. The JTTZ formula led to safe and significant improvements in the blood glucose, blood lipids, and weight levels; relieved symptoms; and enhanced β cell function for T2D patients with obesity and hyperlipidemia. The JTTZ formula has shown that it could potentially be developed as an alternative medicine for patients with T2D, particularly those who cannot tolerate metformin or other hypoglycemic drugs. This trial was registered with Clinicaltrials.gov NCT01471275.http://dx.doi.org/10.1155/2018/9519231 |
| spellingShingle | Xiaotong Yu Lipeng Xu Qiang Zhou Shengping Wu Jiaxing Tian Chunli Piao Hailong Guo Jun Zhang Liping Li Shentao Wu Meizhen Guo Yuzhi Hong Weirong Pu Xiyan Zhao Yang Liu Bing Pang Zhiping Peng Song Wang Fengmei Lian Xiaolin Tong The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial International Journal of Endocrinology |
| title | The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial |
| title_full | The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial |
| title_fullStr | The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial |
| title_full_unstemmed | The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial |
| title_short | The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial |
| title_sort | efficacy and safety of the chinese herbal formula jttz for the treatment of type 2 diabetes with obesity and hyperlipidemia a multicenter randomized positive controlled open label clinical trial |
| url | http://dx.doi.org/10.1155/2018/9519231 |
| work_keys_str_mv | AT xiaotongyu theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT lipengxu theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT qiangzhou theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT shengpingwu theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT jiaxingtian theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT chunlipiao theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT hailongguo theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT junzhang theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT lipingli theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT shentaowu theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT meizhenguo theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT yuzhihong theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT weirongpu theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT xiyanzhao theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT yangliu theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT bingpang theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT zhipingpeng theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT songwang theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT fengmeilian theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT xiaolintong theefficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT xiaotongyu efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT lipengxu efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT qiangzhou efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT shengpingwu efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT jiaxingtian efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT chunlipiao efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT hailongguo efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT junzhang efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT lipingli efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT shentaowu efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT meizhenguo efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT yuzhihong efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT weirongpu efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT xiyanzhao efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT yangliu efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT bingpang efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT zhipingpeng efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT songwang efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT fengmeilian efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial AT xiaolintong efficacyandsafetyofthechineseherbalformulajttzforthetreatmentoftype2diabeteswithobesityandhyperlipidemiaamulticenterrandomizedpositivecontrolledopenlabelclinicaltrial |