Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a special diet and exercise program can help older adults who have insulin resistance—a condition where the body doesn’t use insulin well—and a lack of motivation known as apathy. The researchers want to find out if this program improves both insulin resistance and feelings of apathy, and whether adding soybean to the diet makes a difference. Participants will receive all their meals for 12 weeks and will engage in supervised exercise. They will also undergo tests that measure how well their bodies handle insulin and fill out questionnaires about their feelings and health.

To be eligible for this study, participants need to be adults with a body mass index (BMI) of 30 or higher and must not have significant depression or other health conditions that could interfere with the study. The trial is open to individuals aged 18 to 93, regardless of gender. Participants can expect to follow a structured diet and exercise plan, receive support from the research team, and contribute to valuable research that could help improve health outcomes for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Body mass index (BMI) greater than or equal to 30kg/m2
• • Mini-Mental State Examination (MMSE) \> 25
• • Geriatric Depression Scale-15 (GDS-15) \< 6
• • Apathy Evaluation Scale - score \> 30 or GDS-15 Apathy subscale - score ≥ 2
• • Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3
• • Sedentary: \< 90 minutes of moderate to vigorous physical activity/week.
• Exclusion Criteria:
• • Subjects with a diagnosis of Type 2 diabetes received more than five years ago.
• • Participants who have type 1 diabetes
• • Participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight.
• • Participants who are on concomitant therapy with glucocorticoids.
• • Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction.
• • Participants that have had a fluctuation in body weight \>5% in the preceding 2 months.
• • Any other conditions that may impede testing of the study hypothesis.

Trial Officials