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The effects of Diacylglycerol edible oil intervention in patients with chronic metabolic syndrome combined with asymptomatic hyperuricemia: a multicenter, prospective, double-blind, randomized controlled clinical study

The effects of Diacylglycerol edible oil intervention in patients with chronic metabolic syndrome combined with asymptomatic hyperuricemia: a multicenter, prospective, double-blind, randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085336
Enrollment
Unknown
Registered
2024-06-05
Start date
2023-05-12
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic metabolic syndrome combined with asymptomatic hyperuricemia

Interventions

Control group:Regular treatment + Three meals of food cooked with triacylglycerol edible oil
Diacylglycerol edible oil group:Regular treatment + Three meals of food cooked with diacylglycerol edible oil

Sponsors

The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients aged 25-60 years old (regardless of gender, including patients aged 25 and 60 years old). (2) In accordance with Western diagnostic standards for chronic metabolic syndrome (refer to Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)). ? Abdominal obesity (that is, central obesity): waist circumference male =90 cm, female =85 cm. ? Hyperglycemia: fasting blood sugar =6.1 mmol/L or 2 h after glucose load blood sugar =7.8 mmol/L and/or diagnosed diabetes mellitus and treatment. ? Hypertension: blood pressure =130/85 mmHg and/or recognized as hypertension and treated; ? Fasting TG=1.70 mmol/L. ? Fasting HDL-C<1.04mmol/L. The above inclusion criteria meet the three inclusion criteria (?, ?, and ?) or more. Meanwhile, the following conditions should be met: BMI < 32 kg/m2, fasting blood glucose < 12mmol/L, 2 h postmeal blood glucose < 16.7 mmol/L, HbA1c < 9.5%, blood pressure < 160/100 mmHg, fasting TG < 5.65 mmol/L, and fasting LDL-C < 4.9 mmol/L. (3) Meeting the Western diagnostic criteria for asymptomatic hyperuricemia (refer to the Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019)): no gout attack occurred when the blood uric acid level exceeded 420µmol/L (7.0mg/dL) for two times on different days. (4) Willing to obey the doctor's intervention plan and cooperate with follow-up, informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) BMI=32 kg/m2, fasting blood glucose =12mmol/L, 2 h post-meal blood glucose =16.7 mmol/L, HbA1c =9.5%, blood pressure =160/100 mmHg, fasting TG=5.65 mmol/L, fasting LDL-C=4.9 mmol/L, meet one or more of the above. (2) Patients diagnosed with type 1 diabetes mellitus or gestational diabetes mellitus or other types of diabetes mellitus, secondary hypertension, secondary hyperlipidemia or secondary hyperuricemia. (3) The use of diuretics in drug combination. (4) Advanced gouty arthritis, severe renal calculus, joint deformation. (5) Those who have used hormone drugs in the last 6 months. (6) Patients with previous history of pancreatitis, severe bone destruction, and severe limb dysfunction. (7) Patients with cardiovascular and cerebrovascular, liver, kidney, hematopoietic, rheumatic immune system, retinopathy and other serious primary diseases, or known serious diseases affecting their survival (such as tumor or AIDS), or mental or legal disabilities (such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 times the upper limit of normal value, Serum creatinine (Cr) > the upper limit of normal, serum creatinine clearance < 30ml/min and cardiac function above grade 3). (8) Allergic to the ingredients of the test products. (9) Women who are pregnant, planning to become pregnant or breastfeeding. (10) Have participated in or are participating in other clinical researchers within 1 month. (11) The researchers judged that the participants should not participate in the experiment or were easy to lose.

Design outcomes

Primary

MeasureTime frame
serum uric acid;

Secondary

MeasureTime frame
fasting insulin;fasting C-peptide;2 h postprandial C-peptide;glycosylated hemoglobin;homeostatic model assessment of insulin resistance;fasting blood glucose;2h postprandial blood glucose;total cholesterol;triglyceride;high-density lipoprotein cholesterol;low-density lipoprotein cholesterol;blood pressure;weight;body mass index;waist circumference;average intima-media thickness of common carotid artery;

Countries

China

Contacts

Public ContactDanping Xu

The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)

xudanping@hotmail.com+86 138 2640 6099

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026