Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-27 @ 3:54 AM
Study NCT ID:
NCT02241603
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Resistance and Reward
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Insulin Resistance and Reward Signaling in Obesity
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRRSO
Brief Summary:
Obesity is a common problem in the Veteran population as at least 1 in 3 Veterans are obese. When obese people eat food they have less response in areas of the brain that sense pleasure (reward). Decreased pleasure response to food predicts future weight gain. It is not known if this poor brain response is reversible or why obese people's brains respond this way. Insulin in the brain regulates the brain's sensing of pleasure. As people gain weight the function of insulin becomes impaired. The investigators will study if impaired function of insulin is related to a poor brain response to food and if this brain response predicts voluntary intake of food and response to a diet. The investigators will also study if improving the function of insulin with weight loss improves the brain response. These studies will improve the understanding as to why weight loss is difficult and inform us if improving insulin signaling is a potential way to treat obesity.
Detailed Description:
The current research proposal will investigate the relationship of insulin sensitivity to brain reward signaling. In most obese individuals, insulin signaling is impaired (insulin resistance). Preclinical animal studies suggest that insulin resistance in brain regions important for reward contribute to overeating. This proposal aims to test these hypotheses in humans and to determine if these characteristics are pertinent to clinical outcomes (food intake and weight loss). In humans increased body mass index (BMI) and weight gain occur with decreased food consumption-induced neural activation (consummatory reward) in the caudate of the dorsal striatum. It has been speculated that diminished consummatory reward causes overeating and prevents weight loss, however, this hypothesis has not been directly tested. Further, mechanisms for impaired food consumption-induced neural activation in obesity have not been investigated.
The primary research outcomes of the proposed study are: 1) insulin sensitivity determined by hyperinsulinemic euglycemic clamp, 2) food consumption-induced neural activation as determined by blood-oxygen dependent functional magnetic resonance imaging (BOLD fMRI) scanning, 3) caloric intake at a buffet meal, and 4) weight loss during a weight loss intervention. Based on screening and baseline outcome assessments half of participants will be enrolled in a weight loss intervention and then repeat outcomes measures after intervention. Others will only complete baseline outcome measures. Secondary measures of the study include whole brain activation analyses, neuroendocrine hormone measurement at the time of imaging, psychometric measures including eating behaviors and personality characteristics, and measures of reward sensitivity.
The primary research outcomes of the proposed study are: 1) insulin sensitivity determined by hyperinsulinemic euglycemic clamp, 2) food consumption-induced neural activation as determined by blood-oxygen dependent functional magnetic resonance imaging (BOLD fMRI) scanning, 3) caloric intake at a buffet meal, and 4) weight loss during a weight loss intervention. Based on screening and baseline outcome assessments half of participants will be enrolled in a weight loss intervention and then repeat outcomes measures after intervention. Others will only complete baseline outcome measures. Secondary measures of the study include whole brain activation analyses, neuroendocrine hormone measurement at the time of imaging, psychometric measures including eating behaviors and personality characteristics, and measures of reward sensitivity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: