Survivorship Promotion In Reducing IGF-1 Trial

Study Overview

This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors

N/A

Breast Cancer
Prostate Cancer
Lung Cancer
Colon Cancer
Melanoma of Skin
Endometrial Cancer
Liver Cancer
Pancreatic Cancer
Rectal Cancer
Kidney Cancer
Other Solid Malignant Tumors

DRUG: Metformin
BEHAVIORAL: Coach Directed Behavioral Weight Loss
BEHAVIORAL: Self-control weight loss

J14148
IRB00035653 (OTHER Identifier) (OTHER: JHMIRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-04-21	Results First Submitted 2020-08-26	Last Update Submitted that met QC Criteria 2024-08-04
First Submitted that Met QC Criteria 2015-04-30	Results First Submitted that Met QC Criteria 2020-08-26	Last Update Posted (ACTUAL) 2024-08-28
First Posted (ACTUAL) 2015-05-01	Results First Posted 2020-09-16	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Self-Directed In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.	BEHAVIORAL: Self-control weight loss
EXPERIMENTAL: Coach Directed Behavioral Weight Loss The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight	BEHAVIORAL: Coach Directed Behavioral Weight Loss Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and mai
EXPERIMENTAL: Metformin This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals	DRUG: Metformin Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Self-Directed

In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.

BEHAVIORAL: Self-control weight loss

EXPERIMENTAL: Coach Directed Behavioral Weight Loss

The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight

BEHAVIORAL: Coach Directed Behavioral Weight Loss

Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and mai

EXPERIMENTAL: Metformin

This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals

DRUG: Metformin

Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for

Primary Outcome Measures	Measure Description	Time Frame
IGF-1 Levels	Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.	6 months

Secondary Outcome Measures	Measure Description	Time Frame
IGF-1 Levels	IGF-1 at 12 months	12 months
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)	IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.	6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Women and men ages 18 or older
Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.
Have a BMI of 25 kg/m^2 or greater and weight <=400 lbs.
Willingness to accept randomization to each of the three arms
Willingness to change diet, physical activity, and weight
Regular access to computer with a reliable Internet connection
Ability to send and receive emails
Ability to complete online forms
Access to phone
Willingness to provide written informed consent

Women who are breastfeeding, pregnant, or planning pregnancy within the next year
Medication-treated diabetes
Fasting blood glucose >=200 mg/dL, or fasting blood glucose >=126 and <200 mg/dL and HbA1C >=7%
Current or prior regular use of metformin within the past 3 months
Uncontrolled concurrent medical condition likely to limit compliance with the study interventions
Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date
Have a prior history of lactic acidosis by self-report
Prior or planned bariatric surgery
Have significant renal disease or dysfunction defined as Estimated glomerular filtration rate (eGFR)<45
Have significant hepatic dysfunction [Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (ULN) or reported liver disease]
Self-reported average consumption of > 14 alcoholic drink per week
Currently enrolled or planned to enroll in weight loss program
Hemoglobin <9 g/dl
Platelet count <100
White blood cell count (WBC) <2.5
Plans to relocate from the area within one years
Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Maryland Cigarette Restitution Fund

Investigators

PRINCIPAL_INVESTIGATOR: Jessica Yeh, PhD, Johns Hopkins University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller E, White K, Appel LJ, Mueller NT. Increases in Circulating and Fecal Butyrate are Associated With Reduced Blood Pressure and Hypertension: Results From the SPIRIT Trial. J Am Heart Assoc. 2022 Jul 5;11(13):e024763. doi: 10.1161/JAHA.121.024763. Epub 2022 Jun 22.
Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller ER, Appel LJ, Mueller NT. A behavioral weight-loss intervention, but not metformin, decreases a marker of gut barrier permeability: results from the SPIRIT randomized trial. Int J Obes (Lond). 2022 Mar;46(3):655-660. doi: 10.1038/s41366-021-01039-2. Epub 2022 Jan 6.
Hu JR, Yeh HC, Mueller NT, Appel LJ, Miller ER 3rd, Maruthur NM, Jerome GJ, Chang AR, Gelber AC, Juraschek SP. Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial. Nutrients. 2021 Jul 31;13(8):2673. doi: 10.3390/nu13082673.
Mueller NT, Differding MK, Zhang M, Maruthur NM, Juraschek SP, Miller ER 3rd, Appel LJ, Yeh HC. Metformin Affects Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids: A Randomized Trial. Diabetes Care. 2021 Jul;44(7):1462-1471. doi: 10.2337/dc20-2257. Epub 2021 May 18.
Juraschek SP, Plante TB, Charleston J, Miller ER, Yeh HC, Appel LJ, Jerome GJ, Gayles D, Durkin N, White K, Dalcin A, Hermosilla M. Use of online recruitment strategies in a randomized trial of cancer survivors. Clin Trials. 2018 Apr;15(2):130-138. doi: 10.1177/1740774517745829. Epub 2018 Jan 24.

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