NCT01780870

Brief Summary

The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet. The investigators will also study the following:

  1. 1.The impact of diet induced weight loss on hormones/adipokine levels
  2. 2.The impact of diet induced weight loss on leptin tolerance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

May 1, 2017

Enrollment Period

4.3 years

First QC Date

January 29, 2013

Results QC Date

January 6, 2017

Last Update Submit

May 1, 2017

Conditions

ObesityWeight Loss

Keywords

OverweightObesityObeseWeight loss

Outcome Measures

Primary Outcomes (3)

  • The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks

    The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

    8 weeks

  • The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks

    The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

    8 weeks

  • The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks

    The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

    8 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy

Weight loss group

ACTIVE COMPARATOR

Full Meal replacement Protocol

Dietary Supplement: Weight loss group (Full meal replacement products)

Interventions

Weight loss group (Full meal replacement products)DIETARY_SUPPLEMENT

In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase

Also known as: Full meal replacement products (1280-1320 kcal/day)
Weight loss group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult men and women, age 18-50
  • English speaking
  • Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
  • Willing to enroll in a low calorie full meal replacement weight loss program
  • Willing and able to take part in a multi year study involving visits
  • Adult men and women, age 18-50
  • English speaking
  • Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
  • Willing and able to take part in a multi year study involving visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

ObesityWeight LossOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Dr. Christos Mantzoros
Organization
Beth Israel Deaconess Medical Center
cmantzor@bidmc.harvard.edu
6176678633

Study Officials

  • Christos Mantzoros, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 31, 2013

Study Start

September 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 7, 2017

Results First Posted

August 7, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)