Improving Insulin Resistance in Gynecological Cancer Patients

NCT04139694 | Withdrawn DMC

• 1 other identifier: RP-19-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• body mass index (BMI)

  24 weeks

• body composition

  24 weeks

• glucose tolerance

  24 weeks

Study Arms (2)

Cinnamon with Food Plan

EXPERIMENTAL

Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements.

Dietary Supplement: Food plan with cinnamon supplementation

Food Plan Only

ACTIVE COMPARATOR

Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements.

Behavioral: Food plan without cinnamon supplementation

Interventions

Food plan with cinnamon supplementation DIETARY_SUPPLEMENT

cinnamon twice daily plus follow Cardiometabolic diet

Also known as: Gaia Herbs Cinnamon Bark

Cinnamon with Food Plan

Food plan without cinnamon supplementation BEHAVIORAL

Cardiometabolic diet only

Food Plan Only

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no previous diagnosis of diabetes
• no other cancer diagnosis (excluding skin)
• no chronic use of medication(s) interfering with glucose metabolism

Sponsors & Collaborators

• Woman's: lead
• Woman's Hospital, Louisiana: collaborator
• Dietitians in Integrative and Functional Medicine DPG: collaborator

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutrition Services Manager

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 25, 2019
• Study Start: March 16, 2020
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

US (1)