Improving Insulin Resistance in Gynecological Cancer Patients

Woman's

Status: Withdrawn

Conditions: Insulin Resistance

Treatments: Dietary Supplement: Food plan with cinnamon supplementation; Behavioral: Food plan without cinnamon supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04139694

RP-19-002

Details and patient eligibility

About

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.

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cinnamon with Food Plan

Experimental group

Description:

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

Treatment:

Dietary Supplement: Food plan with cinnamon supplementation

Food Plan Only

Active Comparator group

Description:

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

Treatment:

Behavioral: Food plan without cinnamon supplementation