Insulin Resistance and Type 2 Diabetes
Conditions
Brief summary
In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who undergo GBP experience normalization of their blood glucose and are able to discontinue their anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part result from excluding the duodenum from the flow of nutrients. With the use of enteral feeding tubes, we hope to better understand the factors in the human gut that may predispose obese individuals to the development of insulin resistance and T2DM.
Interventions
PROCEDUREPlacement of nasogastric feeding tube
Glucose tolerance test via nasogastric feeding tube 50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3
PROCEDURENasojejunal feeding tube
Glucose tolerance test via nasojejunal feeding tube 50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for lean, healthy control subjects: 1. Fasting plasma glucose (FPG) \< 100 2. Age 18 to 55 3. BMI 18.5 to 24.9 kg/m2 4. Stable weight for prior 3 months Inclusion criteria for prediabetic individuals: 1. Based on American Diabetes Association criteria of FPG \> 100 and \<126 2. Age 18 to 55 3. BMI 35 to 60 kg/m2 4. Stable weight for prior 3 months Inclusion criteria for diabetic individuals: 1. Diagnosis of type 2 diabetes mellitus (T2DM) for \< 5 years 2. Hemoglobin A1c \< 8% 3. Age 18 to 55 4. BMI 35 to 60 kg/m2 5. Stable weight for prior 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Incretin effect | 3 days |
Outcome results
None listed