Diabetes Type 2 Clinical Trial
Official title:
Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Verified date | February 2023 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).
Status | Completed |
Enrollment | 24 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: - Ages 30-65 years - A1c < 8.5% - BMI > 18.5 Exclusion Criteria: - known malignancy, anemia, kidney disease, and/or liver disease - untreated thyroid disease - uncontrolled hypertension - initiation of any anti-diabetes medications within the last 3 months - greater than 5% change in weight in the last 3 months - current or recent steroid use in the last 3 months - for women: pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | Yale Center for Clinical Investigation | New Haven | Connecticut |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Silver Palate Kitchens Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Eating behavior | measure of food provided and returned | day 1 | |
Other | Eating behavior | measure of food provided and returned | day 14 | |
Other | Eating behavior | measure of food provided and returned | day 28 | |
Primary | Change in glycemic variability | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. | day 1 | |
Primary | Change in glycemic variability | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. | 14 days | |
Primary | Change in glycemic variability | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. | day 28 | |
Secondary | Changes in weight | change in weight from baseline | day 1 | |
Secondary | Changes in weight | change in weight from baseline | day 14 | |
Secondary | Changes in weight | change in weight from baseline | day 28 | |
Secondary | Changes in BMI | change in BMI from baseline | upon screening | |
Secondary | Changes in BMI | change in BMI from baseline | day 1 | |
Secondary | Changes in BMI | change in BMI from baseline | day 14 | |
Secondary | Changes in BMI | change in BMI from baseline | day 28 | |
Secondary | Change in glucose levels | change in blood glucose levels | upon enrollment | |
Secondary | Change in glucose levels | change in blood glucose levels | day 1 | |
Secondary | Change in glucose levels | change in blood glucose levels | day 14 | |
Secondary | Change in glucose levels | change in blood glucose levels | day 28 |
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