Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02250066 |
| Other study ID # |
IlamUMS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 17, 2014 |
| Last updated |
July 16, 2017 |
| Start date |
January 2012 |
| Est. completion date |
April 2014 |
Study information
| Verified date |
July 2017 |
| Source |
Ilam University of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
investigators evaluated the efficacy of two types of diet with different macronutrients, on
prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting
glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were
randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or
control group (n=109) and followed for 2 years. For calculating daily energy requirement in
subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal
body weight with no attempt for losing body weight. Control group were encouraged to follow
the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and
saturated fat to less than 10 percent of total energy. The primary outcome variable was
incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association
criteria.
Description:
322 participants were randomized and stratified into a control group and two study groups
according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were
anthropometric measurements, food diary and laboratory exams. Anthropometric measurements
were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours
after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein
(LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university
hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in
all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body
weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with
use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from
fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from
protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA
in this group was olive oil. In the intervention groups diet regimen was written for each
participant by a registered dietitian. Group three or the control group was encouraged to
follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy
consumption and saturated fat to less than 10 percent of total energy.
