Effect of a Dietary Intervention on Intracellular Lipid Levels, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
Megadott ok: The study was not initiated due to COVID-19 restrictions during the original study start date. After the restrictions were lifted, the study was redesigned and entered as a different study.
Key facts
- Where
- Washington D.C., Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Physicians Committee for Responsible MedicineWashington D.C., Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Physicians Committee for Responsible Medicine
- Trial code
- NCT04088981
- Record updated
- 2025. június 27.
- Original description
The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on changes in intramyocellular and hepatocellular lipid content in adults with type 2 diabetes. Changes in insulin sensitivity and glycemic control will also be assessed in this study. The study duration is 44 weeks.Read full original descriptionShow less
Physicians Committee for Responsible Medicine, A Randomized, Crossover Trial of the Effect of a Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on changes in intramyocellular and hepatocellular lipid content in adults with type 2 diabetes. Changes in insulin sensitivity and glycemic control will also be assessed in this study. The study duration is 44 weeks.
Inclusion: Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other that sulfonylureas; Age ≥18 years; Body mass index 26-40 kg/m2; Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months; HbA1c between 6-10.5% (42-88 mmol/mol).
Exclusion: Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas; Use of recreational drugs in the past 6 months; Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications, systemic steroids, antidepressants (tricyclics, MAOIs, SSRIs), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta blockers; Inability to maintain current medication regimen; Metal implants, such as a cardiac pacemaker or an aneurysm clip; History of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome; Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use; Unstable medical or psychiatric illness; Evidence of an eating disorder; Smoking during the past six months; Pregnancy or intention to become pregnant during the study period; Likely to be disruptive in group sessions; Already following a low-fat, vegan diet; Lack of English fluency; Inability or unwillingness to participate in all components of the study; Intention to follow another weight-loss method during the trial; Participants will also review and complete the Yale MRI Safety Questionnaire to determine eligibility for the study.