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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK132517-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control.
The main question[s] it aims to answer are:
Participants will have:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1 | Other | Intervention before and after study with subjects with uncontrolled T2DM to measured brain glucose transport specifically in the occipital lobe during acute hyperglycemia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition visits | Behavioral | Participants will receive exercise and dietary counseling from a nutritionist and registered dietician with extensive experience with diabetes and obesity every 2 weeks during the 12 wee |
| Measure | Description | Time Frame |
|---|---|---|
| Brain glucose concentration in the occipital cortex week 0 | Intracerebral concentrations of glucose across the occipital cortex , as measured by MRS will be compared following hyperglycemic clamp in T2DM individuals at baseline (week0). | week 0 |
| Brain glucose concentration in the occipital cortex week 12 | Intracerebral concentrations of glucose across the occipital cortex will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| CGM metrics | Glycemic variability, time above range, time in range and time below range will be assessed by using EasyGV between groups at baseline and after 12 weeks of intervention | weeks 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Sanchez Rangel, MD | Contact | 203-785-6430 | elizabeth.sanchezrangel@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Sanchez Rangel, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital (YNHH) Research Unit (HRU) | Recruiting | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Intensification of diabetes regimen | Other | Patient will meet every 2 weeks in person or have regular phone calls with an endocrinologist to review glucose control and intensification of the diabetes regimens. Will follow the general strategies outlined in the Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. |
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| Continuous glucose monitor (CGM) | Other | Individuals with uncontrolled T2DM will be asked use a CGM during the 12 week intervention, to monitor glucose control. Target blood glucose levels will be between 80-130 mg/dl before meals and < 180 mg/dl at bedtime. Individuals not at goal with glycemic targets will undergo intensification of their regimen. Throughout the study, individuals will be contacted via telephone, email or through additional clinic visits as deemed necessary for maintenance of glycemic control. |
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| D004700 | Endocrine System Diseases |