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NCT07801378
Comparing Two Low-Carbohydrate Diets With a Standard Diet in Type 2 Diabetes
Conditions: Diabete Mellitus, Obesity & Overweight, Hypertriglyceridaemia
Sex: All
Ages: 30 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 168
Sponsor: National Nutrition and Food Technology Institute
Summary
Type 2 diabetes is often accompanied by high blood triglycerides and excess weight, and diet plays a central role in managing these conditions together. The purpose of this study is to compare the effects of two moderate low-carbohydrate diets - one higher in protein and one higher in fat - against a standard diet, on blood sugar control, blood lipids (especially triglycerides), body weight, and blood pressure in adults with type 2 diabetes, hypertriglyceridemia, and overweight or obesity.
Eligibility Criteria
Inclusion Criteria:
* Diagnosed with type 2 diabetes mellitus for at least 6 months
* Fasting serum triglycerides between 200-399 mg/dL
* Body mass index (BMI) between 25 and 35 kg/m\^2
* Age between 30 and 70 years
* If taking medication for diabetes, dyslipidemia, or hypertension, dose stable for at least 8 weeks prior to enrollment
* Able to follow the prescribed diet
* Willing and able to provide informed consent
Exclusion Criteria:
* Fasting triglycerides of 400 mg/dL or higher, or lower than 200 mg/dL
* HbA1c greater than 10.5%
* eGFR less than 30 mL/min/1.73m\^2
* Type 1 diabetes or rare metabolic disorders
* Severe renal, cardiac, or hepatic disease, or active pancreatitis
* Established cardiovascular disease (myocardial infarction, stroke, coronary angioplasty or bypass surgery, or heart failure)
* Pregnancy, breastfeeding, or planning pregnancy during the study
* Psychiatric disorder or social circumstances that would prevent adherence to the dietary protocol
* Change in dose or type of diabetes, lipid-lowering, or blood pressure medication within 8 weeks before enrollment or during the study
* Use of weight-loss medications, protein supplements, or probiotics
* Body weight change greater than 3% within the past 6 months
* Withdrawal of consent to continue participation
Source: ClinicalTrials.gov (NCT07801378). StuddyBuddy aggregates publicly available trial information.