Obesity, Type 2 Diabetes
Conditions
Keywords
bariatric surgery, l, liver insulin resistance,
Brief summary
This is a pilot study to show that it is possible to identify the specific types of fats in blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these fats to learn more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver disease is the accumulation of fat in the liver of people who have minimal alcohol exposure. Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and predicts development of Type 2 Diabetes. The study doctors are interested in looking at the relationship between liver fat and insulin resistance.
Interventions
Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery \--------------------------------------------------------------------------------
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects eligible to participate in the study will be: 1. Adults over age 18; 2. Patients enrolled in the bariatric surgery clinic who are planning to undergo and have insurance approval for bariatric surgery; 3. Insulin sensitive (based on HOMA-IR calculated from screening labs) OR insulin resistant (based on HOMA-IR and or personal history of diet controlled diabetes) 4. Able and willing to give informed consent.
Exclusion criteria
The following will exclude subjects from study participation: 1. Clinically significant medical issues outside of diabetes (eg, pregnancy, cardiovascular disease, uncontrolled pulmonary disease). If female and of child bearing potential, a pregnancy test will be performed and confirmed negative prior to participation in the study and prior to the scheduled glucose clamp procedure. 2. A history of hematologic (platelets \<100 x107/L), hepatic (liver function tests \[LFTs\] \>2X upper limit of normal), renal (Creatinine \>1.5 mg/dL), pulmonary/ cardiac abnormalities (ie, abnormal electrocardiogram \[EKG\]). 3. Use of anti-diabetes medication, anticoagulants, or medication that might alter lipids. If the subject has a history of diabetes, it should be controlled by diet alone. 4. Inflammatory or celiac intestinal disease; 5. Untreated thyroid disease; 6. Excessive alcohol use, illicit drug use, or active untreated psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Sensitivity | Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hyperinsulinemic-euglycemic Clamp hyperinsulinemic-euglycemic clamp
Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
\--------------------------------------------------------------------------------
Glucose | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Hyperinsulinemic-euglycemic Clamp |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 4 |
| insulin sensitivity | 3.55 HOMA IR STANDARD_DEVIATION 2.9 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Insulin Sensitivity
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperinsulinemic-euglycemic Clamp | Insulin Sensitivity | 8 m value | Standard Deviation 2 |
p-value: <0.05t-test, 2 sided
Primary
Insulin Sensitivity
Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 150-180 minute interval of the clamp
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperinsulinemic-euglycemic Clamp | Insulin Sensitivity | 8.5 mg glucose /kg FFM/min | Standard Error 2 |