Improving Insulin Resistance in Gynecological Cancer Patients

Not Applicable

Withdrawn

• Conditions: Insulin Resistance
• Interventions: Dietary Supplement: Food plan with cinnamon supplementation; Behavioral: Food plan without cinnamon supplementation

• Registration Number: NCT04139694
• Lead Sponsor: Woman's

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-25
• Study Start: 2020-03-16
• Status Verified: 2020-05
• Primary Completion: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-19
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cinnamon with Food Plan	Food plan with cinnamon supplementation	Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements.
Food Plan Only	Food plan without cinnamon supplementation	Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements.

Primary Outcome Measures

Name	Time	Method
Improvement in mean glucose concentration	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
body mass index (BMI)	24 weeks	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.
body composition	24 weeks	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.
glucose tolerance	24 weeks	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.

Trial Locations

Locations (1)

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States