A Randomized, Crossover Trial to Assess the Effects of Diets Containing Lean Beef vs. White Meat on Pancreatic Beta-cell Function in Men and Women With Prediabetes

Midwest Center for Metabolic and Cardiovascular Research1 site in 1 country29 target enrollmentOctober 7, 2022

ConditionsPreDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PreDiabetes
Sponsor: Midwest Center for Metabolic and Cardiovascular Research
Enrollment: 29
Locations: 1
Primary Endpoint: Ratio of incremental area under the curve (iAUC) for C-peptide to iAUC for glucose
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess and compare the effects of usual diets containing lean beef vs. lean poultry on pancreatic beta-cell responses in men and women with prediabetes.

Registry

clinicaltrials.gov

Start Date

October 7, 2022

End Date

September 22, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Midwest Center for Metabolic and Cardiovascular Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female 18 to 74 y of age, inclusive.
•Subject has a BMI of 25.0-39.9 kg/m2, inclusive.
•Subject has a Vein Access Scale score of 7-
•Subject has prediabetes as indicated by a fasting plasma glucose of 100-125 mg/dL and/or HbA1c of 5.7%-6.4% at screening.
•Subject is normally active and judged by the Investigator to be in general good health on the basis of medical history and screening measurements.
•Subject is willing to consume study-related foods and follow the dietary instructions during each 4-week treatment period.
•Subject is willing to come to the clinic for study food pick-up if needed.
•Subject is willing to follow his/her usual physical activity pattern throughout the study period.
•Subject agrees to avoid meat, poultry, seafood, and eggs, other than the study entrées, for the duration of the treatment periods.
•Subject has no plans to change smoking habits during the study period.

Exclusion Criteria

•Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
•Subject has fasting blood glucose ≥ 126 mg/dL and/or HbA1c ≥ 6.5% at screening and/or known type 1 or type 2 diabetes mellitus.
•Subject has atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic \[e.g., myocardial infarction, angina, transient ischemic attack, or stroke of carotid origin\] or \> 50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
•Subject has history or presence of a clinically significant health condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
•Subject has a history of cancer in the prior 2 years, other than non-melanoma skin cancer or carcinoma in situ of the cervix.
•Subject has uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) at screening.
•Subject has unstable use (defined as initiation or change in dose) of anti-hypertensive medication or thyroid hormone replacement within 4 weeks of screening (Appendix 1).
•Subject has used alpha- or beta-adrenergic blockers and/or high-dose (\> 25 mg/d) thiazide diuretics within 4 weeks of screening (Appendix 1).
•Subject has used diabetes medications including any alpha-glucosidase inhibitor, biguanide (metformin), thiazolidinedione, dipeptidyl peptidase-4 inhibitor, meglitinide, sulfonylurea, Sodium-glucose Cotransporter-2 inhibitor, or GLP-1 receptor agonist within 4 weeks of screening (Appendix 1).
•Subject has used systemic corticosteroids within 4 weeks of screening (Appendix 1).

Outcomes

Primary Outcomes

Ratio of incremental area under the curve (iAUC) for C-peptide to iAUC for glucose

Time Frame: 4 weeks

Secondary Outcomes

Glucagon(4 weeks)
Glucagon-like petide-1 (GLP-1)(4 weeks)
Tumor necrosis factor alpha(4 weeks)
High-sensitivity C-reactive protein(4 weeks)
Interleukin-6(4 weeks)
Insulin sensitivity(4 weeks)
Fasting C-peptide(4 weeks)
Insulin(4 weeks)
Fibrinogen(4 weeks)
Mixed meal tolerance test (MTT) Disposition index(4 weeks)
Homeostasis model assessments of pancreatic beta-cell function (HOMA2%B)(4 weeks)
Homeostasis model assessments of insulin sensitivity (HOMA2%S)(4 weeks)
Glucose-dependent inhibitory polypeptide (GIP)(4 weeks)