NCT07801378Not yet recruiting
Comparing Two Low-Carbohydrate Diets With a Standard Diet in Type 2 Diabetes
Comparison of Two Moderate Low-Carbohydrate Diets (High-Protein and High-Fat) Versus a Standard Diet on Metabolic Indices in Patients With Type 2 Diabetes, Hypertriglyceridemia, and Overweight or Obesity: A Three-Arm Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- 20 Sept 2026
- Primary completion date
- 20 Sept 2026
- Lead sponsor
- National Nutrition and Food Technology Institute
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07801378
What you commit to
- Study type: Interventional
- Planned participants: 168
- From 20 Sept 2026 to the primary completion date, 20 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
- Psychiatric disorder or social circumstances that would prevent adherence to the dietary protocol
Lab values
- 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
Other
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Body weight change greater than 3% within the past 6 months
- Withdrawal of consent to continue participation
Who the study is looking for
- 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
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.