Clinical trial

Comparing Two Low-Carbohydrate Diets With a Standard Diet in Type 2 Diabetes

Opening soon · Not applicable · 0 countries · Registry ID NCT07801378

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabete Mellitus, Obesity & Overweight, Hypertriglyceridaemia

Full registry 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

Treatments and study arms

High-Protein Low-Carbohydrate Diet

Other

A calorie-restricted (500 kcal/day below baseline needs) diet providing 40% of energy from complex carbohydrates, 30% from fat (20% unsaturated with a 4:1 MUFA/PUFA ratio, 10% saturated), and 30% from protein (15% plant-based), delivered over 12 weeks as 5 individualized daily meals.

High-Fat Low-Carbohydrate Diet

Other

A calorie-restricted (500 kcal/day below baseline needs) diet providing 40% of energy from complex carbohydrates, 45% from fat (35% unsaturated with a 4:1 MUFA/PUFA ratio, 10% saturated), and 15% from protein, delivered over 12 weeks as 5 individualized daily meals.

Standard diet

Other

A calorie-restricted (500 kcal/day below baseline needs) standard diet providing 55% of energy from complex carbohydrates, 30% from fat (20% unsaturated with a 4:1 MUFA/PUFA ratio, 10% saturated), and 15% from protein, delivered over 12 weeks as 5 individualized daily meals.

Primary outcomes

Change in fasting serum triglyceride (TG) levelBaseline to Week 12

Study locations

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No public site location was included in this record. Check the original registry for updates.