An interventional study of Euglycemic hyperinsulinemic clamp with tracer enhancement and Euglycemic hyperinsulinemic clamp with tracer enhancement in Type1 Diabetes Mellitus and Adiposity, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 12 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Yale University · Not applicable, Interventional, and Basic science
The purpose of this study is to assess the effects of adiposity on resistance to insulin's ability to suppress hepatic glucose production and to stimulate peripheral glucose metabolism in adolescents with type 1 diabetes. In addition, this study will also examine the role of fatty liver disease on the insulin resistance of obesity in adolescents with type 1 diabetes.
A major focus of this program of research will be directed at advancing the understanding of the metabolic consequences of obesity and puberty in adolescents with T1D. Thus, an innovative aspect of this research is that it will be the first to use these sophisticated metabolic techniques to examine the effects of obesity and hepatic steatosis on insulin sensitivity in pubertal adolescents with T1D; namely, the 2-step hyperinsulinemic euglycemic clamp with tracer enhancement, which will allow for definition of hepatic and peripheral insulin resistance, glycerol turnover, and glucose and fat oxidation. Further, a second novel aspect is that this will be the first study to utilize gold standard MRI methods to quantify and compare intrahepatic fat content in lean and obese adolescents with T1D. This will allow a global and more detailed understanding of the potential alterations of insulin's effects on key insulin sensitive tissues in youth that are impacted by both T1D and obesity. Furthermore, evaluation of biomarkers for insulin resistance and fatty liver disease in this population will be performed for the first time.
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All Participants:
Adolescents with T1D:
Lean, young adults with T1D:
Exclusion Criteria:
Adolescents with T1D and overweight/obesity
Procedure: Euglycemic hyperinsulinemic clamp with tracer enhancement
Lean adolescents with T1D
Procedure: Euglycemic hyperinsulinemic clamp with tracer enhancement
Young adults with T1D with a euglycemic hyperinsulinemic clamp with tracer enhancement
Procedure: Euglycemic hyperinsulinemic clamp with tracer enhancement
To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.
A comparison control group of 36 lean young adults with T1D will also be enrolled, since they will be unaffected by the adverse metabolic effects of puberty or obesity.
Rate of Glucose Metabolism
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low does insulin phase, this reflects hepatic glucose metabolism, which is reported here. A higher glucose infusion rate number indicates more sensitivity to insulin; a lower number means more resistance to insulin.
Time frame: 120 minutes
Rate of Lipid Metabolism
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low dose insulin phase, glycerol turnover (rate of appearance) can reflect adipose specific insulin sensitivity, which is reported here. Insulin should suppress glycerol turnover. A higher number reflects more resistance to insulin; a lower number means more sensitivity to insulin.
Time frame: 120 minutes
Hepatic Sensitivity to Low Dose Insulin
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the low dose insulin phase reflects hepatic sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin. This is calculated as the low dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.
Time frame: 120 minutes
Peripheral Sensitivity to High Dose Insulin
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the high dose phase reflects peripheral sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin. This is calculated as the high dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.
Time frame: 240 minutes
| Milestone | Adolescent Overweight | Adolescent Typical | Young Adult |
|---|---|---|---|
| Started | 13 | 7 | 2 |
| Completed | 13 | 7 | 2 |
| Not completed | 0 | 0 | 0 |
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low does insulin phase, this reflects hepatic glucose metabolism, which is reported here. A higher glucose infusion rate number indicates more sensitivity to insulin; a lower number means more resistance to insulin.
| mg/kg/min | Adolescent Overweight | Adolescent Typical |
|---|---|---|
| Rate of Glucose Metabolism | 1.74 ± 0.77 | 1.56 ± 0.41 |
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. During the low dose insulin phase, glycerol turnover (rate of appearance) can reflect adipose specific insulin sensitivity, which is reported here. Insulin should suppress glycerol turnover. A higher number reflects more resistance to insulin; a lower number means more sensitivity to insulin.
| mg/kg/min | Adolescent Overweight | Adolescent Typical |
|---|---|---|
| Rate of Lipid Metabolism | 0.099 ± 0.077 | 0.12 ± 0.099 |
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the low dose insulin phase reflects hepatic sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin. This is calculated as the low dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.
| percentage of suppression of Ra glucose | Adolescent Overweight | Adolescent Typical |
|---|---|---|
| Hepatic Sensitivity to Low Dose Insulin | -27.9 ± 25.8 | -35.8 ± 15.3 |
Insulin function will be measured using a euglycemic hyperinsulinemic clamp procedure. A clamp measures insulin sensitivity. Insulin should suppress glucose production. Change of the glucose rate of appearance (which is reported here, and the glucose rate of appearance is measured here utilizing isotopic enrichment) during the high dose phase reflects peripheral sensitivity to insulin. A greater degree of decline reflects more sensitivity to insulin; a smaller number means more resistance to insulin. This is calculated as the high dose insulin phase glucose rate of appearance minus the baseline phase glucose rate of appearance, divided by the basal phase glucose rate of appearance and multiplied x 100.
| percentage of suppression of Ra glucose | Adolescent Overweight | Adolescent Typical |
|---|---|---|
| Peripheral Sensitivity to High Dose Insulin | -75.99 ± 58.8 | -96.48 ± 32.5 |
Collected over 6 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adolescent Overweight | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Adolescent Typical | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Young Adult | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
Baseline characteristics are provided for each group.
| Age, Continuous(years) | Adolescent Typical Weight | Adolescent Overweight/Obese | Young Adult | Total |
|---|---|---|---|---|
| Mean | 14.3 ± 1.11 | 14.5 ± 1.19 | 20.65 ± 2.48 | 15.57 ± 2.03 |
| Sex: Female, Male(Participants) | Adolescent Typical Weight | Adolescent Overweight/Obese | Young Adult | Total |
|---|---|---|---|---|
| Female | 4 | 8 | 0 | 12 |
| Male | 3 | 5 | 2 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Adolescent Typical Weight | Adolescent Overweight/Obese | Young Adult | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 0 | 3 |
| Not Hispanic or Latino | 6 | 11 | 2 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Adolescent Typical Weight | Adolescent Overweight/Obese | Young Adult | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 7 | 11 | 2 | 20 |
| More than one race | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Adolescent Typical Weight | Adolescent Overweight/Obese | Young Adult | Total |
|---|---|---|---|---|
| United States | 7 | 13 | 2 | 22 |
| percentage of glycated hemoglobin(percentage) | Adolescent Typical Weight | Adolescent Overweight/Obese | Young Adult | Total |
|---|---|---|---|---|
| Mean | 7.32 ± 0.60 | 7.74 ± 0.41 | 6.35 ± 0.49 | 7.48 ± 0.62 |
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