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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK029953 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. Both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.
Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes | Experimental | Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner. |
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| Participants without diabetes | Experimental | Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycogen loading | Other | Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes | We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes. | Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Glycogenolysis in Subjects With Type 2 Diabetes | Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes. | Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks |
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Inclusion Criteria:
Age 30-75
BMI 20-35kg/m^2
Participants with type 2 diabetes:
Exclusion Criteria:
Pregnancy or breast feeding
Morbidities precluding participation
Participants with type 2 diabetes:
Participants without diabetes:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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Subject enrolled after consent were screened to meet inclusion criteria. If not met subjects were excluded.
14 Type 2 Diabetes and 15 without Diabetes subjects were randomized to receive, either Glycogen loading or Non-Glycogen loading meal during visit 1. All subjects were tested for Glycogen loading and Non-Glycogen loading meal in a randomized order.
1Type 2 Diabetes and 2 without Diabetes subjects did not participate in visit 2.
17 Type 2 Diabetes subjects were screened, 1 subject did not meet eligibility criteria, 2 subjects withdrew from the study.
17 subjects without Diabetes were screened, 2 subjects withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 2 Diabetes - GL Then NGL | Participants with Type 2 Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout |
| FG001 | Type 2 Diabetes - NGL Then GL | Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout |
| FG002 | Participants Without Diabetes - GL Then NGL | Participants with no Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout |
| FG003 | Participants Without Diabetes - NGL Then GL | Participants with no Diabetes received Non-Glycogen loading (NGL)followed by Glycogen loading (GL) meal after 3-6 weeks of washout |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Visit |
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| Washout (3-6 Weeks) |
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| Second Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 2 Diabetes | High Carbohydrate (glycogen loading): Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. Low carbohydrate (No Glycogen Loading): Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. Baseline characteristics of all subjects with Type 2 Diabetes reported. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes | We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes. | Gluconeogenesis (GNG) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects with type 2 diabetes. | Posted | Mean | Full Range | umol/kgFFM/min | Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks |
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Across the study duration. GL or NGL meal for a period of 3 days and an overnight infusion protocol, followed by washout for approximately 3-6 weeks. Second visit GL or NGL meal for a period of 3 days and an overnight infusion protocol.
There are no safety endpoints as there were no drugs involved and study risks were limited to that of blood draw only.
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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 | Type 2 Diabetes - GL Then NGL | Participants with Type 2 Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout |
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• Though unlikely, it is possible that additional steps to load hepatic glycogen maybe necessary (e.g., late night snack: high carb in GL and isocaloric low carb in NGL) to maximize differences in liver glycogen contents between visits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rita Basu | University of Alabama at Birmingham | 2059341200 | rbasu@uabmc.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 27, 2022 | Nov 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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A total of 34 subjects participated.
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| No Glycogen Loading | Other | Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. |
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| Rates of Gluconeogenesis in Healthy Subjects | Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects. | Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Participants Without Diabetes | High Carbohydrate (glycogen loading): Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. Low carbohydrate (No Glycogen Loading): Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study. Baseline characteristics of all subjects without Diabetes reported. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Weight (Kg) | Mean | Standard Deviation | Kg |
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| BMI (Kg/m^2) | Mean | Standard Deviation | Kg/m^2 |
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| Fasting Plasma Glucose (mmol/L) | Mean | Standard Deviation | mmol/L |
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| HbA1C | Mean | Standard Deviation | % of Glycosylated Haemoglobin |
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Type 2 Diabetes after a Non-Glycogen Loading meal |
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| Secondary | Rates of Glycogenolysis in Subjects With Type 2 Diabetes | Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes. | Glycogenolysis (GGL) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects with type 2 diabetes. | Posted | Mean | Full Range | umol/kgFFM/min | Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks |
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| Secondary | Rates of Gluconeogenesis in Healthy Subjects | Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects. | Gluconeogenesis (GNG) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects without diabetes. | Posted | Mean | Full Range | umol/kgFFM/min | Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Type 2 Diabetes - NGL Then GL | Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Participants Without Diabetes - GL Then NGL | Participants with no Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Participants Without Diabetes - NGL Then GL | Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout | 0 | 8 | 0 | 8 | 0 | 8 |
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