Pre-diabetes Clinical Trial
Official title:
Short-term Impact of a Low Carbohydrate/High Unsaturated Fat Diet on Hepatic Transcriptomics and Lipidomics in Individuals With Pre-diabetes - A Pilot Study
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. NAFLD is defined as an excessive accumulation of lipids within hepatocytes in the absence of significant alcohol consumption or other causes of chronic liver disease. These patients usually present with hepatic steatosis observed on imaging studies and elevated liver enzymes with clinical features of insulin resistance (IR), including pre-diabetes, type 2 diabetes mellitus (T2DM), arterial hypertension, dyslipidemia, and visceral obesity. The minimum criterion for a histologic diagnosis of NAFLD is >5 percent steatotic hepatocytes in a liver tissue section. The exact mechanism for the development of NAFLD is unclear, although the current evidence indicates that it is likely a complex interplay among neurohormones, intestinal dysbiosis, nutrition, and genetics. IR plays a crucial role in NAFLD pathophysiology mainly by increasing adipocyte lipolysis, resulting in the circulation of more free fatty acids available for hepatic uptake and increasing hepatic de novo lipogenesis. There is yet no approved pharmacologic option for the treatment of NAFLD. Current international guidelines on NAFLD emphasize the importance of lifestyle modifications for all patients with NAFLD and recommend 7-10% of weight loss and a "healthy diet", without suggesting any particular diet. Recent data provide some support for the beneficial role of low carbohydrate (CHO)/high unsaturated fatty acid (both monounsaturated (MUFAs) and polyunsaturated (PUFAs)) dietary patterns for decreasing hepatic steatosis. This proposal addresses this important research gap by leading to advances regarding the impact of a short-term low CHO/high PUFAs/MUFAs dietary intervention on improving hepatic gene expression profiles and lipid composition in individuals with pre-diabetes. The proposed study is unique because all meals and foods will be provided to participants under carefully controlled isocaloric conditions to maintain a constant bodyweight with optimal energy and macronutrient intake control. The primary objective of the proposed research is to investigate how replacement of dietary CHOs by unsaturated fatty acids (both PUFAs and MUFAs) affects liver fat composition and liver transcriptomics in subjects with pre-diabetes.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Enrolling by invitation |
NCT05367024 -
Broccoli Effect on Glycated Haemoglobin (HbA1c)
|
N/A | |
| Completed |
NCT02933424 -
Project Plant Protein: the P3 Study in Humans
|
N/A | |
| Withdrawn |
NCT02400450 -
Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes
|
N/A | |
| Completed |
NCT02656212 -
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
|
Phase 1 | |
| Completed |
NCT02330276 -
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
|
Phase 1 | |
| Completed |
NCT01488279 -
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
|
N/A | |
| Completed |
NCT00831129 -
A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs
|
Phase 2/Phase 3 | |
| Completed |
NCT00536250 -
Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth
|
N/A | |
| Recruiting |
NCT05563090 -
Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
|
||
| Active, not recruiting |
NCT04991142 -
Models of Nutrition From Continuous Glucose Monitors
|
||
| Completed |
NCT02759055 -
Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard)
|
N/A | |
| Completed |
NCT00775684 -
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
|
N/A | |
| Completed |
NCT03695913 -
Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
|
N/A | |
| Completed |
NCT04051008 -
CTSI Pilot: Improving Adherence to Diabetic Diet
|
N/A | |
| Recruiting |
NCT04897945 -
A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
|
N/A | |
| Not yet recruiting |
NCT04442451 -
Mechanisms of Fatigability With Diabetes
|
N/A | |
| Not yet recruiting |
NCT05925933 -
High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes
|
N/A | |
| Active, not recruiting |
NCT05654051 -
The SLIM LIVER Study
|
Phase 2 | |
| Completed |
NCT02919397 -
Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
|
N/A |