Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Insulin Sensitivity Clinical Trial

Official title:

Lifestyle Intervention for Improving Metabolic and Motivational Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649176
• Other study ID #: PBRC 2022-028
• Secondary ID: 4R00AG065419-03
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Pennington Biomedical Research Center
• Contact: Amber Dragg, PhD
• Phone: 12257633050
• Email: Amber.Dragg[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. The main questions the study aims to answer are:

1. Does the diet and exercise program improve insulin resistance and apathy?

2. Does the addition of soybean to the diet enhance the effect? Participants will be given all meals for 12 weeks and will exercise under supervision. They will undergo a test of insulin sensitivity and complete questionnaires.

Researchers will compare the groups given:

1. A diet to moderate the blood glucose response that contains soybean; and

2. A diet to moderate the blood glucose response that does not contain soybean.

Description:

This randomized trial will examine the blood glucose moderating effect of a diet and exercise program in 40 older adults with obesity, insulin resistance, and apathy. The primary objective of this study is to examine the effect of a diet and exercise program on insulin sensitivity and apathy and determine if the addition of soybean to the diet enhances the effect. The primary outcomes of the study are insulin sensitivity measured using the hyperinsulinemic euglycemic clamp test and apathy evaluated using the Apathy Evaluation Scale.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apathy
• Insulin Resistance
• Insulin Sensitivity

Intervention

Other:
• Diet without soy
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the experimental diet but does not contain soy.
• Diet with soy
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Solomon TP, Haus JM, Kelly KR, Cook MD, Filion J, Rocco M, Kashyap SR, Watanabe RM, Barkoukis H, Kirwan JP. A low-glycemic index diet combined with exercise reduces insulin resistance, postprandial hyperinsulinemia, and glucose-dependent insulinotropic polypeptide responses in obese, prediabetic humans. Am J Clin Nutr. 2010 Dec;92(6):1359-68. doi: 10.3945/ajcn.2010.29771. Epub 2010 Oct 27. — View Citation

Solomon TP, Haus JM, Kelly KR, Cook MD, Riccardi M, Rocco M, Kashyap SR, Barkoukis H, Kirwan JP. Randomized trial on the effects of a 7-d low-glycemic diet and exercise intervention on insulin resistance in older obese humans. Am J Clin Nutr. 2009 Nov;90(5):1222-9. doi: 10.3945/ajcn.2009.28293. Epub 2009 Sep 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test	12 weeks
Primary	Apathy	Apathy will be evaluated using the Apathy Evaluation Scale	12 weeks