Obesity/overweight with type 2 diabetes complicated by hypertriglyceridemia
Conditions
Interventions
control group:Hedan Capsules
control group:Hedan capsules placebo
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age range of 18-70 years (including 70 years). 2.Diagnosis of type 2 diabetes (T2DM) according to classification criteria (reference: 1999 WHO criteria). 3.Mild hypertriglyceridemia, defined as 1.7 mmol = TG < 5.0 mmol/L. 4.Mildly elevated blood glucose, defined as 6.5% = HbA1c = 8% (based on valid test results within 14 days prior to screening). 5.Participants who have been receiving monotherapy with oral metformin for at least 3 months, with a stable dose of =1000 mg/day. 6.BMI (Body Mass Index) between 24 kg/m^2 and 30 kg/m^2. 7.Patients with concomitant hypercholesterolemia requiring treatment with statin drugs and/or ezetimibe, with a stable dose for at least 3 months. 8.Inclusion criteria also require participants to meet the diagnostic criteria for TCM (Traditional Chinese Medicine) "Phlegm-Dampness/Stasis of Blood": Blood Stasis Syndrome: Intermittent or persistent presence of symptoms or signs such as chest tightness, dark lips, fixed or stabbing pain, purplish or spotted skin, numbness in limbs; dark tongue color, or with ecchymosis or petechiae, dark or tortuous sublingual veins; taut or pulseless pulse, deep and string-like or string-delayed pulse. Having one or more symptoms or signs, and tongue and pulse characteristics matching the above criteria indicate Blood Stasis Syndrome. Phlegm-Dampness Syndrome: Intermittent or persistent presence of symptoms or signs such as body obesity, feeling of heaviness in the head and body, nausea, phlegm and sputum, chest tightness, epigastric fullness; fat or pale tongue, greasy or slippery tongue coating; slippery or string-slippery pulse. Having one or more symptoms or signs, and tongue and pulse characteristics matching the above criteria indicate Phlegm-Dampness Syndrome. 9.Participants voluntarily agree to participate in the study and have signed an "Informed Consent Form."
Exclusion criteria
Exclusion criteria: 1.Patients with acute complications of diabetes and familial hypertriglyceridemia. 2.Patients with hypertriglyceridemia induced by medications such as estrogen or glucocorticoids. 3.Those who have used diabetes medications other than metformin in the three months prior to the study. 4.Individuals who have taken medications such as niacin, bile acid sequestrants, or fish oil with indications for lowering triglycerides in the three months prior to enrollment. 5.Individuals who experienced a weight loss or gain of more than 4 kg in the three months prior to the study. 6.Patients currently using heparin, thyroid medications, and other drugs that affect lipid metabolism. 7.Poorly controlled hypertension, with systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg. 8.Individuals with congenital heart disease, severe cardiac conditions (such as heart failure, unstable angina, or myocardial infarction), rheumatic heart disease, kidney disease, chronic kidney damage (creatinine >133 µmol/L), severe liver disease, gastrointestinal disorders (such as peptic ulcers or malabsorption syndrome or enteritis), and endocrine disorders other than diabetes. 9.Individuals with a history of recurrent gallstones or kidney stones. 10.Those with a history of hyperphagia or weight-loss bariatric surgery. 11.Individuals with a history of pancreatitis. 12.Serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 2.5 times the upper limit of normal. 13.Patients with malignant tumors or active tuberculosis. 14.Individuals with psychiatric disorders. 15.Patients with diarrhea or those who abuse laxatives. 16.Individuals who are allergic to the investigational drugs involved in the study or have poor compliance. 17.Regular alcohol drinkers. 18.Participants who have been involved in other drug studies within the three months prior to the trial. 19.Individuals with a tendency for bleeding. 20.Women of childbearing age who have the possibility of pregnancy: those who test positive for pregnancy in urine before randomization, lactating participants, or those planning to conceive who are unwilling to adopt sufficient contraceptive measures during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| four items of blood lipid ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine;Urine routine;Insulin levels;HbA1c levels;Hepatic function test;Renal function test ;Plasma Glucose (PG) levels;Four items of blood coagulation; | — |
Countries
China
Contacts
Public ContactChen Yanyan
Fuwai Hospital Chinese Academy of Medical Sciences
Outcome results
None listed