To conduct a trial with good participant retention that compared the effects of two diets on HbA1c and other health-related outcomes in overweight or obese adults with T2D or prediabetes (HbA1c>6%).

Study Number: 35

Year: 2014

Study Design(COUNTRY 1=RCT 2= Systematic Review 3=Non-randomized controlled 4= single arm 5= post hoc analysis 6=Non-systematic review 7. Network meta-analysis 8=other 9 follow up to study): 1

Study background and AIM: To conduct a trial with good participant retention that compared the effects of two diets on HbA1c and other health-related outcomes in overweight or obese adults with T2D or prediabetes (HbA1c>6%).

6 Months or longer: N

Number of subjects and analysis: 33

Low-carb diet arm: "Target: E: none Carb: initially, 20-50g net carb to induce nutritional ketosis Protein: none Fat: none Intake E: 1693.7kcal/d Carb: 57.8 net carbs/d; 14.4%E Protein: 105.7g/d; 24.2%E Fat:110.2g/d; 58%E"

Comparison diet ARM(S): "Medium-carb, low-fat, calorie-restricted, diet (MCCR) consistent with ADA guidelines. Targets: Carb: 45-50%E Protein: same as before study Fat: advised to lower Taught how to count carbs using unit method by registered dietician experienced in teaching about ADA diet. Intake E: 1380.8kcal/d Carbs: 138.5 net carbs/d; 40.7%E Protein: 67.9g/d; 20.5%E Fat: 56.1g/d; 35.1%E "

Outcomes Studied: "Primary: HbA1c Secondary: lipids, insulin resistance (HOMA), C-reactive protein, weight, SBP, DBP, and psychological states."

Result Summary: The LC diet SS improved HbA1c, weight, BMI, waist size, and HDL-C compared to standard diet. Outcomes for other lipids and blood pressure were NSS for both groups.

FBG, Other Glucose Measures: "WG: N BG: N MCCR DIET WG NSS. BG NSS"

FBG WG Sign: 0

FBG BG Sign: 0

HbA1c: "HbA1C & % achieving a decrease in HbA1c ≥0.5% WG: Y BG: Y Baseline→3 mo HbA1c LCK diet 6.6%→6.0 WG SS, p<0.01 MCCR diet 6.9%→6.9 WG NSS BG SS, p<0.05 % achieving a decrease in HbA1c ≥0.5% LCK diet: 56% MCCR diet: 22% BG SS "

HbA1c WG Sign: 1

HbA1c BG Sign: 1

Total C: NR

Total C WG Sign: *

Total C BG: *

HDL-C: "WG: N BG: N MCCR diet WG NSS. BG NSS "

HDL-C WG Sig: 0

HDL-C BG Sig: 0

LDL-C: "WG: N BG: N MCCR diet WG NSS. BG NSS "

LDL-C WG Sig: 0

LDL-C BG Sig: 0

TG: "WG: N BG: N MCCR diet WG NSS. BG NSS "

TG WG Sig: 0

TG BG Sig: 0

TG/HDL-C ratio WG Sig: *

TG/HDL-C ratio BG Sig: *

Weight/bmi, Body Composition: "Weight and BMI WG: Y BG: Y Baseline→3 months; Weight LCK diet 100.1kg→94.6 WG SS p<0.01 MCCR diet 99.7kg→97.1 WG SS p<0.05 BG SS p<0.05 BMI LCK diet 36.2→34.3 WG SS p<0.01 MCCR diet 37.4→36.4 WG SS p<0.05 BG SS, p<0.05 "

Weight/BMI WG Sig: 1

Weight/BMI BG Sig: 1

SBP: "WG: N BG: N MCCR diet WG NSS. BG NSS "

SBP WG Sig: 0

SBP BG Sig: 0

DBP: "WG: N BG: N MCCR diet WG NSS. BG NSS "

DBP WG Sig: 0

DBP BG Sig: 0

Fasting Insulin: "WG: N BG: N MCCR diet WG NSS. BG NSS "

Fasting Insulin WG SS: 0

Fasting Insulin BG SS: 0

Insulin Sensitivity/Resistance: "HOMA2-IR WG: N BG: N MCCR diet WG NSS. BG NSS "

Insulin Receptor Improvement WG sig: 0

Insulin Receptor Improvement BG sig: 0

Inflammation: "C-reactive protein WG: Y BG: N LCK diet 7.3mg/dL→5.8 WG SS, p<0.05 MCCR diet 4.4→3.8 WG SS, p<0.05 BG NSS"

CRP WG sig: 1

CRP BG sig: 0

Diabetes Medication Use: "% who continued use of one or more oral diabetes medications WG: NR BG: Y LCK diet 44% (n = 7) MCCR diet 11% (n = 2) BG SS, p=0.03 "

Safety Adverse Events: "No reported clinically evident hypoglycemia Only SS symptoms: Heartburn BG SS reduction for LCK diet Constipation WG increase for LCK diet General aches and pain WG decrease for LCK diet"

Retention and Compliance: One subject dropped out due to moving.

Other: "Both groups reported SS reductions in carb and sugar cravings, emotional eating, hunger, and eating disinhibition, and increased dietary restraint. Differences BG NSS. The LCK group reported SS decreases in diabetes distress, negative mood between meals, and perceived disconnection between psychological and physical states."

Study Author's Conclusions: "A low-carb diet was more effective than a standard, moderate-carb diet at reducing HbA1c at three months. All subjects in the LCK group showed a decrease in HbA1c."

Abbreviations:

AHA - American Heart Association;

ALT - alanine aminotransferase;

AMDR - acceptable macronutrient distribution range;

AST - aspartate aminotransferase;

BG - between study groups;

BHOB - beta-hydroxybutyrate;

DBP - diastolic blood pressure;

E- energy, caloric intake;

eGFR - estimated glomerular filtration rate;

FBG - fasting blood glucose;

GGT - gamma-glutamyl transferase;

HDL-C - high-density lipoprotein cholesterol;

iGFR - isotope glomerurar filtration rate;

LDL-C - low-density lipoprotein cholesterol;

NAFLD - non-alcoholic fatty liver disease;

NR - not reported (or data needed for calculation not available);

N - no;

NA - not applicable;

NS - not specified;

NSS - not statistically significant;

SBP - systolic blood pressure;

SS - statistically significant;

TG - triglyceride;

total C - total cholesterol;

V - varied, mixed;

WG - within a study group;

WMD - weighted mean difference;

Y - yes

Number of People in Studies:

3,296 Enrolled in randomized controlled trials on 25% or less carbohydrates

2,626 Completed randomized controlled trials on 25% or less carbohydrates

79.67% 82% completion of studies

Duration of Trial

<6 Months

6-9 Months

1 -2 years

>2 years

To conduct a trial with good participant retention that compared the effects of two diets on HbA1c and other health-related outcomes in overweight or obese adults with T2D or prediabetes (HbA1c>6%).

Abbreviations:

Number of People in Studies:

Duration of Trial

# of Trials

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