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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK115894-01A1 | U.S. NIH Grant/Contract | View source |
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Covid
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescent Overweight | Other | Adolescents with T1D and overweight/obesity |
|
| Adolescent Typical | Other | Lean adolescents with T1D |
|
| Young Adult | Other | Young adults with T1D with a euglycemic hyperinsulinemic clamp with tracer enhancement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euglycemic hyperinsulinemic clamp with tracer enhancement | Procedure | To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
All Participants:
Adolescents with T1D:
Lean, young adults with T1D:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Van Name, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Pediatric Diabetes Research Program | New Haven | Connecticut | 06511 | United States |
One participant enrolled but did not have any baseline or study data obtained due to scheduling conflicts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescent Overweight | Adolescents with T1D and body mass index ≥85% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement. 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. |
| FG001 | Adolescent Typical | Adolescents with T1D and body mass index <75% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement. 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. |
| FG002 | Young Adult | Young Adults with T1D and body mass index 18.5 to <25 kg/m2 will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics are provided for each group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescent Typical Weight | Adolescents with T1D and body mass index <75% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group. | Posted | Mean | Standard Deviation | mg/kg/min | 120 minutes |
|
6 hours
This is not a longitudinal study, and there was no intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescent Overweight | The study aims to enroll 36 adolescents with T1D and overweight/obesity, 36 lean adolescents with T1D, and 36 young adults with T1D that will receive a euglycemic hyperinsulinemic clamp with tracer enhancement. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Van Name | Yale University | 2037855831 | michelle.vanname@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2018 | Aug 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2022 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Euglycemic hyperinsulinemic clamp with tracer enhancement | Procedure | 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. |
|
| 240 minutes |
| BG001 |
| Adolescent Overweight/Obese |
Adolescents with T1D and body mass index ≥85% will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement. 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. |
| BG002 | Young Adult | Young Adults with T1D and body mass index 18.5 to <25 kg/m2 will undergo a euglycemic hyperinsulinemic clamp with tracer enhancement. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| percentage of glycated hemoglobin | Mean | Standard Deviation | percentage |
|
| OG001 | Adolescent Typical | Lean adolescents with T1D. 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. |
|
|
|
| Primary | 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. | Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group. | Posted | Mean | Standard Deviation | mg/kg/min | 120 minutes |
|
|
|
|
| Primary | 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. | Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group. | Posted | Mean | Standard Deviation | percentage of suppression of Ra glucose | 120 minutes |
|
|
|
|
| Primary | 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. | Only adolescents were analyzed due to the availability of data in the aftermath of the COVID shutdown- data were not collected on the young adult group. | Posted | Mean | Standard Deviation | percentage of suppression of Ra glucose | 240 minutes |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Adolescent Typical | The study aims to enroll 36 adolescents with T1D and overweight/obesity, 36 lean adolescents with T1D, and 36 young adults with T1D a euglycemic hyperinsulinemic clamp with tracer enhancement. 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Young Adult | Young adults with T1D a euglycemic hyperinsulinemic clamp with tracer enhancement. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |