Clinical trial NCT03714451: Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Official title: Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Silver Palate Kitchens Inc.
First posted: 2018-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded randomized
Primary purpose: OTHER

Brief summary: To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).

Detailed description: The plan is to study 24 participants with T2DM, who are otherwise healthy. The study will be double-blinded and randomized. Participants will first attend a screening visit (Visit #1) to determine eligibility. Then, eligible participants will be asked to wear a FreeStyle Libre Pro continuous glucose monitor (CGM) for up to 14 days (Visit #2). After this 14-day CGM session, participants will be randomly assigned (1:1) to one of two groups that will receive: 1) food products containing onyx sorghum (Onyx Group) or 2) food products with wheat flour (Control Group). The diet intervention will last a total of 28 days. Participants will have weekly visits to pick up food and bi-weekly blood draws (no more than 20mL at each visit). They will also be asked to wear the CGM throughout the diet intervention and will record their food intake in a daily food diary to confirm that the diet intervention is being followed.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glycemic variability
timeFrame: day 1
measure: Change in glycemic variability
timeFrame: 14 days
measure: Change in glycemic variability
timeFrame: day 28
Secondary outcomes:
measure: Changes in weight
timeFrame: day 1
measure: Changes in weight
timeFrame: day 14
measure: Changes in weight
timeFrame: day 28
measure: Changes in BMI
timeFrame: upon screening
measure: Changes in BMI
timeFrame: day 1
measure: Changes in BMI
timeFrame: day 14
measure: Changes in BMI
timeFrame: day 28
measure: Change in glucose levels
timeFrame: upon enrollment
measure: Change in glucose levels
timeFrame: day 1
measure: Change in glucose levels
timeFrame: day 14
measure: Change in glucose levels
timeFrame: day 28
Other outcomes:
measure: Eating behavior
timeFrame: day 1
measure: Eating behavior
timeFrame: day 14
measure: Eating behavior
timeFrame: day 28
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale School of Medicine Department of Endocrinology
name: Renata Belfort de Aguiar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: