Improving Insulin Resistance in Gynecological Cancer Patients

Insulin Resistance Clinical Trial

Official title:

Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04139694
• Other study ID #: RP-19-002
• Status: Withdrawn
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: July 2020

Study information

• Verified date: May 2020
• Source: Woman's
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• previously diagnosed with gynecological cancer and has completed all surgical intervention, chemotherapy, and/or radiation at least 3 months prior to enrollment but not greater than 24 months

• post-menopausal

• BMI > 25 but < 40

Exclusion Criteria:

• no previous diagnosis of diabetes

• no other cancer diagnosis (excluding skin)

• no chronic use of medication(s) interfering with glucose metabolism

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• Food plan with cinnamon supplementation
cinnamon twice daily plus follow Cardiometabolic diet

Behavioral:
• Food plan without cinnamon supplementation
Cardiometabolic diet only

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Woman's	Dietitians in Integrative and Functional Medicine DPG, Woman's Hospital, Louisiana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in mean glucose concentration	To determine whether the addition of cinnamon to the implementation of an integrative and functional (IF) food plan will show a difference of 10 mg% in the mean glucose concentration measured when comparing the baseline and 24 week Oral Glucose Tolerance Test (OGTT) glucose levels.	24 weeks
Secondary	body mass index (BMI)	To determine whether the addition of cinnamon to the implementation of an IF food plan will improve BMI more than just dietary intervention alone. BMI will be calculated by dividing the participant's weight by her height squared.	24 weeks
Secondary	body composition	To determine whether the addition of cinnamon to the implementation of an IF food plan will improve the ratio of fat mass to fat free mass more than just dietary intervention alone. We will measure using a Fit3D scanner that uses infrared cameras to estimate fat mass and fat free mass.	24 weeks
Secondary	glucose tolerance	To determine whether the addition of cinnamon to the implementation of an IF food plan will improve glucose tolerance levels more than just dietary intervention alone. It will be measured using the results of the baseline and final 2-hour Oral Glucose Tolerance Test which measures glucose and insulin at 4 time points.	24 weeks