NCT00186459

Brief Summary

The goal of the study is to define the roles played by resistance to insulin-mediated glucose disposal (insulin resistance) and circulating plasma insulin concentrations in: 1) ability to lose weight; 2) reduction of risk for coronary heart disease as a result of weight loss. We hypothesize that in the setting of caloric restriction, manipulating endogenous insulin concentrations will not alter ability of subjects to lose weight, but will lead to different reduction in CHD risk factors. To test this hypothesis, two parallel studs will be performed. First, obese insulin-resistant individuals will be randomized to one of two equally-hypocaloric diets that vary moderately in proportion of carbohydrate and mono/polyunsaturated fats (lower carbohydrate diet will be associated with greater reduction in endogenous insulin secretion). Second, diabetics treated with insulin secretagogues will be compared to diabetics treated with insulin sensitizers with respect to the same outcomes (secretagogues increase insulin secretion and insulin sensitizers decrease insulin concentrations). Endpoints include weight loss, change in insulin resistance, blood pressure, lipid and lipoproteins, markers of endothelial function, daylong insulin and glucose concentrations: these will be compared, in each of the parallel studies, between the group with insulin-stimulating intervention vs the group with the insulin-sparing intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2000

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

October 1, 2000

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

16.9 years

First QC Date

September 13, 2005

Last Update Submit

December 2, 2024

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight loss

Secondary Outcomes (4)

  • Lipid/lipoprotein changes

  • Blood pressure changes

  • Insulin resistance changes

  • Endothelial function changes

Interventions

Hypocaloric diet of varying macronutrient compositionBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 30-35
  • age 35-65
  • nondiabetic by fasting plasma glucose concentration
  • no active major organ diseases
  • insulin resistant or insulin sensitive

You may not qualify if:

  • anemia
  • pregnant
  • major organ disease
  • active malignancy
  • eating disorder
  • active psychiatric illness
  • chronic inflammatory conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

  • McLaughlin T, Abbasi F, Lamendola C, Yee G, Carter S, Cushman SW. Dietary weight loss in insulin-resistant non-obese humans: Metabolic benefits and relationship to adipose cell size. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):62-68. doi: 10.1016/j.numecd.2018.09.014. Epub 2018 Oct 11.

    PMID: 30497926DERIVED

  • Perelman D, Coghlan N, Lamendola C, Carter S, Abbasi F, McLaughlin T. Substituting poly- and mono-unsaturated fat for dietary carbohydrate reduces hyperinsulinemia in women with polycystic ovary syndrome. Gynecol Endocrinol. 2017 Apr;33(4):324-327. doi: 10.1080/09513590.2016.1259407. Epub 2016 Dec 2.

    PMID: 27910718DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Tracey Lynn McLaughlin

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2000

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

US(1)