CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Phentermine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01616082
NCT01616082N/ACompleted

Effect of Caloric Restriction on Metabolic Biomarkers and Fat Oxidation in Obese Men and Women (Magellan II)

AdventHealth Translational Research Institute·interventional·Posted Jun 11, 2012·Updated Nov 13, 2020

In Brief

A clinical study evaluating Low Calorie Diet (LCD) and Phentermine for Obesity and 2 related conditions. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The purpose of this study is to better understand the different ways our bodies burn fat which may be important for obesity, diabetes, and cardiovascular disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTakeda

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2012
Enrollment StartSep 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago

Interventions

Low Calorie Diet (LCD)behavioral

A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.

Phenterminedrug

Individuals not on track to achieve their target weight by four weeks received the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects were given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision. Protection Against Risk: * Prior to administering any phentermine, a history and physical including EKG will be conducted (at the screening visit) and will be used to determine whether the participant is clear to receive the medication. * Participants will see the study doctor or nurse practitioner at every study visit after the drug is initiated.